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This study aims at estimating the proportion of patients diagnosed with locoregional renal cell carcinoma who are at high risk for recurrence following nephrectomy, describe referral patterns, and characterize treatment in this population. Outcomes including estimation of the incidence of recurrence and disease-free interval following nephrectomy will be reported overall and among the subgroup off patients receiving adjuvant systemic therapy with sunitinib following nephrectomy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| patients with Renal Cell Carcinoma(RCC) | Patients diagnosed with RCC who received a nephrectomy between 01Apr2014 and 31Mar2019 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nephrectomy | Procedure | Surgery performed within the study period |
|
| Measure | Description | Time Frame |
|---|---|---|
| Follow-up Duration | Follow- up time (in years) was duration between index date to the last entry in the medical record, death, or disease recurrence. The date of nephrectomy was considered as index date. | From index date to the last entry in the medical record, death, or disease recurrence, approximately during 5 years (data observed during 9 months of retrospective study) |
| Number of Participants Classified According to Follow-up Plan Determined at First Post-operative Visit | In this outcome measure number of participants were classified according to their follow-up plan determined at first post-operative visit. Follow-up plans were as follows: 1) surveillance, 2) adjuvant systemic therapy (AST), 3) follow-up plan not recorded in the medical record and 4) other. | At first post-nephrectomy visit during approximately during 5 years (data observed during 9 months of retrospective study) |
| Number of Participants With Transfer of Care to a Non-Duke Provider | In this outcome measure number of participants with transfer of care to a non-Duke provider were reported. | At first post-nephrectomy visit during approximately during 5 years (data observed during 9 months of retrospective study) |
| Number of Participants With no Documented Oncologic/RCC Related Care Referrals: Modified High Risk Sub-group | Among number of participants who were followed up for any referral, those participants who had no documented oncologic/RCC related care referrals were recorded and reported. Data for this outcome measure was planned to be collected and analyzed in modified high risk sub-group. | Post-nephrectomy approximately during 5 years (data observed during 9 months of retrospective study) |
| Number of Participants Classified According to Type of Referring Provider for Oncologic/RCC Related Care Referrals: Modified High Risk Sub-group |
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| Measure | Description | Time Frame |
|---|---|---|
| Disease Free Survival (DFS): Modified High Risk Sub-group | DFS was defined as the time interval (in months) from date of nephrectomy to earliest documentation of high-risk of RCC recurrence or death. Data for this outcome measure was planned to be collected and analyzed in modified high risk sub-group. | From nephrectomy up to earliest documentation of high-risk of recurrence or death, approximately during 5 years (data observed during 9 months of retrospective study) |
Inclusion Criteria:
Patients must meet all of the following inclusion criteria to be eligible for data abstraction:
Exclusion Criteria:
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Patients aged 18 years or older who were diagnosed with locoregional RCC and underwent nephrectomy at Duke
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University | Durham | North Carolina | 27710 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34751002 | Derived | Dzimitrowicz H, Esterberg E, Miles L, Zanotti G, Borham A, Harrison MR. Referral and adjuvant treatment patterns after nephrectomy in high-risk locoregional renal cell carcinoma. Cancer Med. 2021 Dec;10(24):8891-8898. doi: 10.1002/cam4.4407. Epub 2021 Nov 9. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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Data collected were observed and evaluated in this study's duration of approximately 9 months.
Medical record data, for participants with locoregional renal cell carcinoma (RCC), who were recommended to go through nephrectomy at Duke from 01 April 2014 to 31 December 2019, were compiled retrospectively by Duke researchers via an institutional database.
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| ID | Title | Description |
|---|---|---|
| FG000 | All Participants | Eligible participants diagnosed with locoregional RCC who were recommended to go through nephrectomy at Duke from 01 April 2014 to 31 December 2019 were included and their data from medical records were evaluated and observed in the study. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Analysis population included all eligible participants whose data were retrieved from medical records and studied.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | Eligible participants diagnosed with locoregional RCC who were recommended to go through nephrectomy at Duke from 01 April 2014 to 31 December 2019 were included and their data from medical records were evaluated and observed in the study. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Follow-up Duration | Follow- up time (in years) was duration between index date to the last entry in the medical record, death, or disease recurrence. The date of nephrectomy was considered as index date. | Analysis population included all eligible participants whose data were retrieved from medical records and studied. | Posted | Median | Full Range | years | From index date to the last entry in the medical record, death, or disease recurrence, approximately during 5 years (data observed during 9 months of retrospective study) |
|
Not applicable as safety data was not collected during the study
Due to non-interventional nature of the study, safety data was not collected.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Participants | Eligible participants diagnosed with locoregional RCC who were recommended to go through nephrectomy at Duke from 01 April 2014 to 31 December 2019 were included and their data from medical records were evaluated and observed in the study. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 27, 2020 | Apr 27, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D002292 | Carcinoma, Renal Cell |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D009392 | Nephrectomy |
| ID | Term |
|---|---|
| D013520 | Urologic Surgical Procedures |
| D013519 | Urogenital Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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Number of participants according to the type of provider who referred for oncologic or RCC related care after nephrectomy were recorded and reported. Type of providers included urologist, primary care, and other. Data for this outcome measure was planned to be collected and analyzed in modified high risk sub-group. |
| Post-nephrectomy approximately during 5 years (data observed during 9 months of retrospective study) |
| Number of Participants Classified According to Type of Provider Referred to for Oncologic/RCC Related Care Referrals: Modified High Risk Sub-group | Number of participants according to the type of provider referred to, for oncologic/RCC related care after nephrectomy were recorded and reported. Type of providers to whom participants were referred included medical oncologist, radiation oncologist, urologist, interventional radiologist, and medical geneticist. Data for this outcome measure was planned to be collected and analyzed in modified high risk sub-group. | Post-nephrectomy approximately during 5 years (data observed during 9 months of retrospective study) |
| Number of Participants Classified According to Reasons for Oncologic/RCC Related Care Referrals: Modified High Risk Sub-group | Number of participants according to reasons for being referred to oncologic or RCC related care after nephrectomy were recorded and reported. Reasons included discussion of adjuvant systemic therapy (AST) options, other discussion of management options, and other. Data for this outcome measure was planned to be collected and analyzed in modified high risk sub-group. | Post-nephrectomy approximately during 5 years (data observed during 9 months of retrospective study) |
| Time to Any Referral for Oncologic/Renal Cell Carcinoma (RCC) Related Care: Modified High Risk Sub-group | After nephrectomy, time (in days) to any referral for oncologic or RCC related care was recorded and reported. Data for this outcome measure was planned to be collected and analyzed in modified high risk sub-group. | Post-nephrectomy approximately during 5 years (data observed during 9 months of retrospective study) |
| Time From Nephrectomy to Subsequent Surgery: Modified High Risk Sub-group | Time from nephrectomy (in months) up to the subsequent surgery was recorded and reported. Data for this outcome measure was planned to be collected and analyzed in modified high risk sub-group. | From nephrectomy up to the subsequent surgery, approximately during 5 years (data observed during 9 months of retrospective study) |
| Number of Participants Classified According to Type of Subsequent Surgery: Modified High Risk Sub-group | Number of participants according to the type of subsequent surgery after nephrectomy were reported. Data for this outcome measure was planned to be collected and analyzed in modified high risk sub-group. | From nephrectomy up to the subsequent surgery, approximately during 5 years (data observed during 9 months of retrospective study) |
| Time From Nephrectomy to Receipt of First-line Adjuvant Systemic Therapy (AST): Modified High Risk Sub-group | Time from nephrectomy up to the first-line AST was recorded and reported. Data for this outcome measure was planned to be collected and analyzed in modified high risk sub-group. | From nephrectomy up to the first-line AST, approximately during 5 years (data observed during 9 months of retrospective study) |
| Number of Participants Classified According to Type of Systemic Agents Received as First-line AST: Modified High Risk Sub-group | Number of participants according to type of systemic agents received as first-line AST were recorded and reported. Data for this outcome measure was planned to be collected and analyzed in modified high risk sub-group. | From nephrectomy up to the first-line AST, approximately during 5 years (data observed during 9 months of retrospective study) |
| Mean of Starting Dose of First-line AST Received: Modified High Risk Sub-group | Mean of starting dose of first-line AST received after nephrectomy was reported. Data for this outcome measure was planned to be collected and analyzed in modified high risk sub-group. | From nephrectomy up to the first-line AST, approximately during 5 years (data observed during 9 months of retrospective study) |
| Number of Participants Who Were Treated With First-line AST as Part of a Clinical Trial in the Adjuvant Setting: Modified High Risk Sub-group | In this outcome measure number of participants who were treated with first-line AST after nephrectomy as a part of clinical trial in adjuvant setting were reported. Data for this outcome measure was planned to be collected and analyzed in modified high risk sub-group. | From nephrectomy up to the first-line AST, approximately during 5 years (data observed during 9 months of retrospective study) |
| Number of Participants Classified According to First-line AST Discontinuation Reasons: Modified High Risk Sub-group | In this outcome measure number of participants were classified according to reason for discontinuation of treatment with first-line AST after nephrectomy. Data for this outcome measure was planned to be collected and analyzed in modified high risk sub-group. | From nephrectomy up to the first-line AST, approximately during 5 years (data observed during 9 months of retrospective study) |
| RCC Related Follow-up Duration After Nephrectomy: Modified High Risk Sub-group | RCC related follow-up duration after nephrectomy was reported. Data for this outcome measure was planned to be collected and analyzed in modified high risk sub-group. | From nephrectomy up to the follow-up, approximately during 5 years (data observed during 9 months of retrospective study) |
| Number of Participants Who Died: Modified High Risk Sub-group | Data for this outcome measure was planned to be collected and analyzed in modified high risk sub-group. | From nephrectomy up to death by any cause, approximately during 5 years (data observed during 9 months of retrospective study) |
| Number of Participants Classified According to Type of Disease Recurrence: Modified High Risk Sub-group | Number of participants according to the type of disease recurrence are reported. Type of disease recurrence were locoregional and distant. Data for this outcome measure was planned to be collected and analyzed in modified high risk sub-group. | From nephrectomy up to disease recurrence, approximately during 5 years (data observed during 9 months of retrospective study) |
| Time From Nephrectomy to Recurrence: Modified High Risk Sub-group | Time from nephrectomy to recurrence (in months) was defined as the time from nephrectomy to the high risk of RCC recurrence or end of participant record or receipt of systemic therapy or death due to any cause. Data for this outcome measure was planned to be collected and analyzed in modified high risk sub-group. | From nephrectomy up to disease recurrence, approximately during 5 years (data observed during 9 months of retrospective study) |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Time from RCC Diagnosis to Nephrectomy | In this baseline measure, duration (in days) from time of RCC diagnosis to nephrectomy was reported. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this baseline measure. | Mean | Standard Deviation | days |
|
| Number of Participants Classified According to Tumor, Node, Metastasis (TNM) stage | In this baseline measure, participants were classified according to their TNM stage. T = size and extent of the main tumor, N = number of nearby lymph nodes that have cancer and M = whether the cancer has metastasized. There are 4 TNM stages from 1 to 4, in which participants were distributed. Stage 1 to 3 refers to cancer is present; higher the stage larger the cancer tumor and more it has spread into nearby tissues. Stage 4 refers to the cancer has spread to distant parts of the body. | Count of Participants | Participants |
|
| Number of Participants Classified According to Tumor Fuhrman (Nuclear) Grade | In this baseline measure, participants were classified according to Fuhrman (nuclear) grade. Grade 1= round or uniform nuclei; nucleoli not discernible or absent; Grade 2= slightly irregular nuclear contours; nucleoli visible at 400X (400 times its actual size); Grade 3= moderately to markedly irregular nuclear contours; nucleoli visible at 100X (100 times its actual size); Grade 4= multilobular nuclei or bizarre nuclei and large and prominent nucleoli. | Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this baseline measure. | Count of Participants | Participants |
|
| Number of Participants Classified According to Clear Cell Predominance | In this baseline measure, participants were classified as "Yes" if they had a clear cell predominance or "No" if they did not had a clear cell predominance. | Count of Participants | Participants |
|
| Mean Tumor Size | In this baseline measure, mean tumor size of participants was reported. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this baseline measure. | Mean | Standard Deviation | centimeter |
|
| Number of Participants Classified According to Tumor Necrosis | In this baseline measure, participants were classified per presence or absence of tumor necrosis. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this baseline measure. | Count of Participants | Participants |
|
| Number of Participants Classified According to Nephrectomy Year | In this baseline measure, number of participants were classified according to year when they underwent nephrectomy. | Count of Participants | Participants |
|
| Number of Participants Classified According to Type of Nephrectomy | In this baseline measure, number of participants according to type of nephrectomy they underwent (full or partial) were reported. | Count of Participants | Participants |
|
| Eastern Cooperative Oncology Group (ECOG) Performance Status | ECOG scale: 0=fully active/able to carry on all pre-disease activities without restriction; 1= restricted in physically strenuous activity but ambulatory and able to carry out work of a light and sedentary nature; 2= ambulatory and capable of all self-care, but unable to carry out any work activities, up and about >50% of waking hours; 3=capable of only limited self-care, confined to bed/chair >50% of waking hours; 4=completely disabled, cannot carry on any self-care, totally confined to bed/chair. | Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this baseline measure. | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Number of Participants Classified According to Follow-up Plan Determined at First Post-operative Visit | In this outcome measure number of participants were classified according to their follow-up plan determined at first post-operative visit. Follow-up plans were as follows: 1) surveillance, 2) adjuvant systemic therapy (AST), 3) follow-up plan not recorded in the medical record and 4) other. | Analysis population included all eligible participants whose data were retrieved from medical records and studied. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure. | Posted | Count of Participants | Participants | At first post-nephrectomy visit during approximately during 5 years (data observed during 9 months of retrospective study) |
|
|
|
| Primary | Number of Participants With Transfer of Care to a Non-Duke Provider | In this outcome measure number of participants with transfer of care to a non-Duke provider were reported. | Analysis population included all eligible participants whose data were retrieved from medical records and studied. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure. | Posted | Count of Participants | Participants | At first post-nephrectomy visit during approximately during 5 years (data observed during 9 months of retrospective study) |
|
|
|
| Primary | Number of Participants With no Documented Oncologic/RCC Related Care Referrals: Modified High Risk Sub-group | Among number of participants who were followed up for any referral, those participants who had no documented oncologic/RCC related care referrals were recorded and reported. Data for this outcome measure was planned to be collected and analyzed in modified high risk sub-group. | Analysis population included participants who were at modified high risk of recurrence. Here 'Overall Number of Participants Analyzed' signifies participants who were followed up for evaluation for any referral. | Posted | Count of Participants | Participants | Post-nephrectomy approximately during 5 years (data observed during 9 months of retrospective study) |
|
|
|
| Primary | Number of Participants Classified According to Type of Referring Provider for Oncologic/RCC Related Care Referrals: Modified High Risk Sub-group | Number of participants according to the type of provider who referred for oncologic or RCC related care after nephrectomy were recorded and reported. Type of providers included urologist, primary care, and other. Data for this outcome measure was planned to be collected and analyzed in modified high risk sub-group. | Analysis population included participants who were at modified high risk of recurrence. Here "Overall Number of Participants Analyzed" signifies participants who were referred for oncologic/RCC-related care. | Posted | Count of Participants | Participants | Post-nephrectomy approximately during 5 years (data observed during 9 months of retrospective study) |
|
|
|
| Primary | Number of Participants Classified According to Type of Provider Referred to for Oncologic/RCC Related Care Referrals: Modified High Risk Sub-group | Number of participants according to the type of provider referred to, for oncologic/RCC related care after nephrectomy were recorded and reported. Type of providers to whom participants were referred included medical oncologist, radiation oncologist, urologist, interventional radiologist, and medical geneticist. Data for this outcome measure was planned to be collected and analyzed in modified high risk sub-group. | Analysis population included participants who were at modified high risk of recurrence. Here "Overall Number of Participants Analyzed" signifies participants who were referred for oncologic/RCC-related care. | Posted | Count of Participants | Participants | Post-nephrectomy approximately during 5 years (data observed during 9 months of retrospective study) |
|
|
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| Primary | Number of Participants Classified According to Reasons for Oncologic/RCC Related Care Referrals: Modified High Risk Sub-group | Number of participants according to reasons for being referred to oncologic or RCC related care after nephrectomy were recorded and reported. Reasons included discussion of adjuvant systemic therapy (AST) options, other discussion of management options, and other. Data for this outcome measure was planned to be collected and analyzed in modified high risk sub-group. | Analysis population included participants who were at modified high risk of recurrence. Here "Overall Number of Participants Analyzed" signifies participants who were referred for oncologic/RCC-related care. | Posted | Count of Participants | Participants | Post-nephrectomy approximately during 5 years (data observed during 9 months of retrospective study) |
|
|
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| Primary | Time to Any Referral for Oncologic/Renal Cell Carcinoma (RCC) Related Care: Modified High Risk Sub-group | After nephrectomy, time (in days) to any referral for oncologic or RCC related care was recorded and reported. Data for this outcome measure was planned to be collected and analyzed in modified high risk sub-group. | Analysis population included participants who were at modified high risk of recurrence. Here "Overall Number of Participants Analyzed" signifies participants who were referred for oncologic/RCC-related care and were evaluable for this outcome measure. | Posted | Median | Full Range | days | Post-nephrectomy approximately during 5 years (data observed during 9 months of retrospective study) |
|
|
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| Primary | Time From Nephrectomy to Subsequent Surgery: Modified High Risk Sub-group | Time from nephrectomy (in months) up to the subsequent surgery was recorded and reported. Data for this outcome measure was planned to be collected and analyzed in modified high risk sub-group. | Analysis population included participants who were at modified high risk of recurrence. Here "Overall Number of Participants Analyzed" signifies participants who had any subsequent surgery after nephrectomy. | Posted | Median | Full Range | months | From nephrectomy up to the subsequent surgery, approximately during 5 years (data observed during 9 months of retrospective study) |
|
|
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| Primary | Number of Participants Classified According to Type of Subsequent Surgery: Modified High Risk Sub-group | Number of participants according to the type of subsequent surgery after nephrectomy were reported. Data for this outcome measure was planned to be collected and analyzed in modified high risk sub-group. | Analysis population included participants who were at modified high risk of recurrence. Here "Overall Number of Participants Analyzed" signifies participants who had any subsequent surgery after nephrectomy. | Posted | Count of Participants | Participants | From nephrectomy up to the subsequent surgery, approximately during 5 years (data observed during 9 months of retrospective study) |
|
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| Primary | Time From Nephrectomy to Receipt of First-line Adjuvant Systemic Therapy (AST): Modified High Risk Sub-group | Time from nephrectomy up to the first-line AST was recorded and reported. Data for this outcome measure was planned to be collected and analyzed in modified high risk sub-group. | Analysis population included participants who were at modified high risk of recurrence. Here "Overall Number of Participants Analyzed" signifies participants who received first-line AST after nephrectomy. | Posted | Median | Full Range | days | From nephrectomy up to the first-line AST, approximately during 5 years (data observed during 9 months of retrospective study) |
|
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| Primary | Number of Participants Classified According to Type of Systemic Agents Received as First-line AST: Modified High Risk Sub-group | Number of participants according to type of systemic agents received as first-line AST were recorded and reported. Data for this outcome measure was planned to be collected and analyzed in modified high risk sub-group. | Analysis population included participants who were at modified high risk of recurrence. Here "Overall Number of Participants Analyzed" signifies participants who received first-line AST after nephrectomy. | Posted | Count of Participants | Participants | From nephrectomy up to the first-line AST, approximately during 5 years (data observed during 9 months of retrospective study) |
|
|
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| Primary | Mean of Starting Dose of First-line AST Received: Modified High Risk Sub-group | Mean of starting dose of first-line AST received after nephrectomy was reported. Data for this outcome measure was planned to be collected and analyzed in modified high risk sub-group. | Analysis population included participants who were at modified high risk of recurrence. Here "Overall Number of Participants Analyzed" signifies participants who received first-line AST after nephrectomy and were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | milligram | From nephrectomy up to the first-line AST, approximately during 5 years (data observed during 9 months of retrospective study) |
|
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| Primary | Number of Participants Who Were Treated With First-line AST as Part of a Clinical Trial in the Adjuvant Setting: Modified High Risk Sub-group | In this outcome measure number of participants who were treated with first-line AST after nephrectomy as a part of clinical trial in adjuvant setting were reported. Data for this outcome measure was planned to be collected and analyzed in modified high risk sub-group. | Analysis population included participants who were at modified high risk of recurrence. Here "Overall Number of Participants Analyzed" signifies participants who received first-line AST after nephrectomy. | Posted | Count of Participants | Participants | From nephrectomy up to the first-line AST, approximately during 5 years (data observed during 9 months of retrospective study) |
|
|
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| Primary | Number of Participants Classified According to First-line AST Discontinuation Reasons: Modified High Risk Sub-group | In this outcome measure number of participants were classified according to reason for discontinuation of treatment with first-line AST after nephrectomy. Data for this outcome measure was planned to be collected and analyzed in modified high risk sub-group. | Analysis population included participants who were at modified high risk of recurrence. Here "Overall Number of Participants Analyzed" signifies participants who received first-line AST after nephrectomy and were evaluable for this outcome measure. | Posted | Count of Participants | Participants | From nephrectomy up to the first-line AST, approximately during 5 years (data observed during 9 months of retrospective study) |
|
|
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| Primary | RCC Related Follow-up Duration After Nephrectomy: Modified High Risk Sub-group | RCC related follow-up duration after nephrectomy was reported. Data for this outcome measure was planned to be collected and analyzed in modified high risk sub-group. | Analysis population included participants who were at modified high risk of recurrence. Here "Overall Number of Participants Analyzed" signifies participants who were followed up related to RCC after nephrectomy. | Posted | Median | Full Range | years | From nephrectomy up to the follow-up, approximately during 5 years (data observed during 9 months of retrospective study) |
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| Primary | Number of Participants Who Died: Modified High Risk Sub-group | Data for this outcome measure was planned to be collected and analyzed in modified high risk sub-group. | Analysis population included participants who were at modified high risk of recurrence. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure. | Posted | Count of Participants | Participants | From nephrectomy up to death by any cause, approximately during 5 years (data observed during 9 months of retrospective study) |
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| Primary | Number of Participants Classified According to Type of Disease Recurrence: Modified High Risk Sub-group | Number of participants according to the type of disease recurrence are reported. Type of disease recurrence were locoregional and distant. Data for this outcome measure was planned to be collected and analyzed in modified high risk sub-group. | Analysis population included participants who were at modified high risk of recurrence. Here "Overall Number of Participants Analyzed" signifies participants who had RCC recurrence after nephrectomy. | Posted | Count of Participants | Participants | From nephrectomy up to disease recurrence, approximately during 5 years (data observed during 9 months of retrospective study) |
|
|
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| Primary | Time From Nephrectomy to Recurrence: Modified High Risk Sub-group | Time from nephrectomy to recurrence (in months) was defined as the time from nephrectomy to the high risk of RCC recurrence or end of participant record or receipt of systemic therapy or death due to any cause. Data for this outcome measure was planned to be collected and analyzed in modified high risk sub-group. | Analysis population included participants who were at modified high risk of recurrence. Here "Overall Number of Participants Analyzed" signifies participants who had RCC recurrence after nephrectomy and were evaluable for this outcome measure. | Posted | Median | Full Range | months | From nephrectomy up to disease recurrence, approximately during 5 years (data observed during 9 months of retrospective study) |
|
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| Other Pre-specified | Disease Free Survival (DFS): Modified High Risk Sub-group | DFS was defined as the time interval (in months) from date of nephrectomy to earliest documentation of high-risk of RCC recurrence or death. Data for this outcome measure was planned to be collected and analyzed in modified high risk sub-group. | Analysis population included participants who were at modified high risk of recurrence. | Posted | Median | 95% Confidence Interval | months | From nephrectomy up to earliest documentation of high-risk of recurrence or death, approximately during 5 years (data observed during 9 months of retrospective study) |
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| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| D009369 | Neoplasms |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| Other |
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| Interventional Radiology |
|
| Medical Geneticist |
|