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| Name | Class |
|---|---|
| Optimapharm | INDUSTRY |
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TGCT is a rare disease that is difficult to manage, surgical resection is the primary treatment currently available. To date no disease registry exists and there is little data available detailing the management of patients with diffuse TGCT (d-TGCT), the burden of d-TGCT for patients (including pain, joint stiffness, swelling, reduced mobility and quality of life) or the economic impact of d-TGCT.
This study aims to collect data by an observational disease registry involving no intervention to the patient or changes to investigators treatment decisions.
GCT is a rare, benign, but potentially locally aggressive and recurrent disease. Treatment pattern and treatment initiation, continuation or changes are solely at the discretion of the physician and the patient.
There will be no attempt to influence the prescribing patterns of any individual treating physician. All medication will be prescribed in the usual standard of care and will not be provided by the study sponsor.
Participation in the study will in no way influence payment or reimbursement for any treatment received by patients during the study.
It is the responsibility of the investigator and his study staff to enter all relevant patient data required for this registry in the electronic Case Report Form (eCRF) and in the patients' medical records.
Approximately 15 sites from up to 6 European Countries (France, Germany, Italy, The Netherlands, Spain and United Kingdom) and 4 sites from the US are planned to participate. The sites will be specialized sites that treat d-TGCT regularly.
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants According to the Management Plan in Patients With Diffuse TGCT (d-TGCT) | The management plan received among the patients was collected from information routinely recorded in the patient files / medical records. | Baseline up to end of observation period (approximately 2 years) |
| Number of Participants According to the Current TGCT Treatment Plan in Patients With Diffuse TGCT (d-TGCT) | The current TGCT treatment plan among the patients was collected from information routinely recorded in the patient files / medical records. | Baseline up to end of observation period (approximately 2 years) |
| Number of Participants Based on Type of Treatment Plan in Patients With Diffuse TGCT (d-TGCT) | Type of treatment plan received among the patients was collected from information routinely recorded in the patient files / medical records. | Baseline up to end of observation period (approximately 2 years) |
| Number of Participants Based on Status of Treatment Plan in Patients With Diffuse TGCT (d-TGCT) | The status of treatment plan among the patients was collected from information routinely recorded in the patient files / medical records. | Baseline up to end of observation period (approximately 2 years) |
| Number of Participants Based on Type of Current TGCT Treatment in Patients With Diffuse TGCT (d-TGCT) | Type of current TGCT treatment among the patients was collected from information routinely recorded in the patient files / medical records. | Baseline up to end of observation period (approximately 2 years) |
| Number of Participants Based on Tumor Severity Classification at Baseline Based on MRI in Patients With Diffuse TGCT (d-TGCT) |
| Measure | Description | Time Frame |
|---|---|---|
| Mean EuroQol Questionnaire (EQ) of 5 Dimensions (5D) Index Score and EQ Visual Analog Scale Score From Baseline Through 24 Months | The EQ-5D-5L questionnaire measures the patient's quality of life (QoL) based on the 5 dimensions mobility, self care, usual activities, pain/discomfort, and anxiety/depression. The EQ-5D index score ranges from 0 (worst QoL) to 1 (best QoL), where lower scores indicate worse clinical outcome. The EQ-5D VAS reports patient's self rated health ranging from 0 (worst health) to 100 (best health you can imagine), where lower scores indicate worse clinical outcome. |
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Inclusion Criteria:
Exclusion Criteria:
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This study enrolled patients with d-TGCT.
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Leader | Daiichi Sankyo | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| David Geffen School of Medicine at UCLA | Los Angeles | California | 90095 | United States | ||
| University of California San Francisco |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36869793 | Derived | Palmerini E, Healey JH, Bernthal NM, Bauer S, Schreuder H, Leithner A, Martin-Broto J, Gouin F, Lopez-Bastida J, Gelderblom H, Staals EL, Mercier F, Laeis P, Ye X, van de Sande M. Tenosynovial Giant Cell Tumor Observational Platform Project (TOPP) Registry: A 2-Year Analysis of Patient-Reported Outcomes and Treatment Strategies. Oncologist. 2023 Jun 2;28(6):e425-e435. doi: 10.1093/oncolo/oyad011. | |
| 33926503 |
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All participants with diffuse TGCT (diagnosed histologically) with a confirmed primary diagnosis or recurrent case were enrolled.
A total of 183 participants who met all eligibility criteria were enrolled in the study at 12 sites in Europe and the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | Tenosynovial Giant Cell Tumors | All participants with diffuse tenosynovial giant cell tumors (d-TGCT) who were enrolled in the study. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Demographic and baseline characteristics were assessed in the Full Analysis Set.
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| ID | Title | Description |
|---|---|---|
| BG000 | Tenosynovial Giant Cell Tumors | All participants with diffuse tenosynovial giant cell tumors (d-TGCT) who were enrolled 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 | Number of Participants According to the Management Plan in Patients With Diffuse TGCT (d-TGCT) | The management plan received among the patients was collected from information routinely recorded in the patient files / medical records. | Management plans were assessed in participants with available data in the Full Analysis Set. Participants may have be included in more than one category. | Posted | Count of Participants | Participants | Baseline up to end of observation period (approximately 2 years) |
|
Treatment-emergent adverse events were not assessed in this non-interventional study.
Treatment-emergent adverse events and serious adverse events were not assessed in this non-interventional study. Adverse drug reactions suspected to be related to pexidartinib were only collated for patients from the United States.
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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 | Overall | All participants with diffuse tenosynovial giant cell tumors (d-TGCT) who were enrolled in the study. |
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This was an observational study and the quality of data has not been verified 100%. Baseline data were checked during on-site visits for all patients enrolled in Europe. Due to the COVID-19 pandemic, the planned on-site monitoring visits in the US could not be performed. Instead, more frequent and detailed remote visits were performed for these sites. Follow-up data for all patients were regularly monitored remotely. A certain amount of incorrect/incomplete data has to be assumed for all sites.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Contact for Clinical Trial Information | Daiichi Sankyo | 908-992-6400 | CTRinfo@dsi.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 | Oct 15, 2020 | Dec 10, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D005870 | Giant Cell Tumors |
| D013586 | Synovitis, Pigmented Villonodular |
| ID | Term |
|---|---|
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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Tumor severity classification was collected from information routinely recorded in the patient files / medical records. ). Tumor severity classification was based on MRI. In this classification scheme, moderate diffuse TGCT is characterized by intra- and/or extra-articular disease, without or with involvement of muscle/tendinous tissue/ligaments. Severe diffuse TGCT is characterized by intra- and extra-articular involvement and involvement of at least one of the 3 structures (muscle/tendinous tissue/ligaments). |
| at Baseline |
| Number of Cases With Complications Due to Surgery in Patients With Diffuse TGCT (d-TGCT) | Complications due to surgery were collected from information routinely recorded in the patient files / medical records. | at Baseline (prior to any d-TGCT therapy) |
| Number of Participants With Tumor Recurrence at Baseline in Patients With Diffuse TGCT (d-TGCT) | Tumor recurrence was collected from information routinely recorded in the patient files / medical records. | at Baseline |
| Time Since Most Recent Tumor Recurrence Until Baseline in Patients With Diffuse TGCT (d-TGCT) | Time since most recent tumor recurrence was collected from information routinely recorded in the patient files / medical records. | at Baseline |
| Time From Baseline to First Tumor Recurrence in Patients With Diffuse TGCT (d-TGCT) | Time from baseline to first tumor recurrence was collected from information routinely recorded in the patient files / medical records. | Baseline up to end of observation period (approximately 2 years) |
| Mean Brief Pain Inventory (BPI) Pain Severity and Interference Score From Baseline Through 24 Months | The BPI short form is a self administered questionnaire that assesses severity of pain, impact of pain on daily function, location of pain, pain medications and amount of pain relief in the past 24 hours or the past week. The BPI pain severity and interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes), where lower scores indicate better clinical outcome. | Baseline up to end of observation period (approximately 2 years) |
| Mean Worst Stiffness Score From Baseline Through 24 Months | The Worst Stiffness numerical rating scale (NRS) is a one-item self-administered, patient-reported outcome questionnaire assessing the "worst" stiffness in the last 24 hours. The NRS for this item ranges from 0 ("no stiffness") to 10 ("stiffness as bad as you can imagine"), where lower scores indicate better clinical outcome. | Baseline up to end of observation period (approximately 2 years) |
| Mean PROMIS Physical Function Score From Baseline Through 24 Months | PROMIS® (Patient-Reported Outcomes Measurement Information System) is a set of person-centered measures that evaluates and monitors physical, mental, and social health. Physical function scores range from 0 (worst physical function) to 100 (best physical function, where higher scores indicate better clinical outcome. | Baseline up to end of observation period (approximately 2 years) |
| Baseline up to end of observation period (approximately 2 years) |
| Mean Number of General Practitioner, Specialist, or Physical Therapy Visits to Assess the Health Resource Utilization in Patients With Diffuse TGCT Through 24 Months | Health resource utilization was assessed by mean number of general practitioner visits, specialist visits, and physical therapy sessions. In addition, the mean number of days in rehabilitation and the number of work days missed were also reported. | 13-24 months before baseline up to end of observation period (approximately 2 years) |
| Median Number of Days in Rehabilitation and Work Days Missed in Patients With Diffuse TGCT Through 24 Months | The median number of days in rehabilitation and the number of work days missed were also reported. | 13-24 months before baseline up to end of observation period (approximately 2 years) |
| Overall TGCT Outcome Status in Patients With Diffuse TGCT (d-TGCT) | TGCT outcome status was collected from information routinely recorded in the patient files / medical records. | At end of observation period (approximately 2 years post-baseline) |
| San Francisco |
| California |
| 94158 |
| United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Medizinische Universität Graz | Graz | 8036 | Austria |
| CHU Nantes | Nantes | 44093 | France |
| Westdeutsches Tumorzentrum | Essen | 45122 | Germany |
| Istituto Ortopedico Rizzoli | Bologna | 40136 | Italy |
| Istituto Nazionale Tumori-Foundazione IRCCS | Milan | 20133 | Italy |
| Leiden University Medical Center | Leiden | 2333 | Netherlands |
| Radboud universitair medisch centrum | Nijmegen | 6525 GA | Netherlands |
| Hospital Sant Pau | Barcelona | 08041 | Spain |
| Hospital Universitario Virgen del Rocio | Seville | 41013 | Spain |
| The Royal Marsden Hospital | London | SW3 6JJ | United Kingdom |
| Nuffield Orthopaedic Centre | Oxford | OX3 7LD | United Kingdom |
| Derived |
| Bernthal NM, Spierenburg G, Healey JH, Palmerini E, Bauer S; TOPP Study Group; Gelderblom H, Staals EL, Lopez-Bastida J, Fronk EM, Ye X, Laeis P, van de Sande MAJ. The diffuse-type tenosynovial giant cell tumor (dt-TGCT) patient journey: a prospective multicenter study. Orphanet J Rare Dis. 2021 Apr 29;16(1):191. doi: 10.1186/s13023-021-01820-6. |
| Other |
|
| years |
|
| Age, Customized | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Tumor location/affected joint | Count of Participants | Participants |
|
| Current symptoms | Count of Participants | Participants |
|
| Most disturbing symptom | Count of Participants | Participants |
|
| Number of participants with current symptoms | Count of Participants | Participants |
|
Participants with diffuse tenosynovial giant cell tumors (d-TGCT) who were assessed within 1st year of the study.
| OG002 | Within 2nd Year | Participants with diffuse tenosynovial giant cell tumors (d-TGCT) who were assessed within 2nd year of the study. |
|
|
| Primary | Number of Participants According to the Current TGCT Treatment Plan in Patients With Diffuse TGCT (d-TGCT) | The current TGCT treatment plan among the patients was collected from information routinely recorded in the patient files / medical records. | The current treatment plan (currently being treated or planned) was assessed in participants with no changes at any data collection point where the data of the previous reported data collection point is being reported in the Full Analysis Set. | Posted | Count of Participants | Participants | Baseline up to end of observation period (approximately 2 years) |
|
|
|
| Primary | Number of Participants Based on Type of Treatment Plan in Patients With Diffuse TGCT (d-TGCT) | Type of treatment plan received among the patients was collected from information routinely recorded in the patient files / medical records. | Type of treatment plans were assessed in participants with available data in the Full Analysis Set. Participants may have be included in more than one category. | Posted | Count of Participants | Participants | Baseline up to end of observation period (approximately 2 years) |
|
|
|
| Primary | Number of Participants Based on Status of Treatment Plan in Patients With Diffuse TGCT (d-TGCT) | The status of treatment plan among the patients was collected from information routinely recorded in the patient files / medical records. | Status of treatment plan was assessed in participants currently being treated or planned to be treated in the Full Analysis Set. Participants with different reported treatment plans during the period (e.g. participants who may have switched treatment plans) are counted as 'currently being treated or planned to be treated' in the corresponding period. | Posted | Count of Participants | Participants | Baseline up to end of observation period (approximately 2 years) |
|
|
|
| Primary | Number of Participants Based on Type of Current TGCT Treatment in Patients With Diffuse TGCT (d-TGCT) | Type of current TGCT treatment among the patients was collected from information routinely recorded in the patient files / medical records. | Status of treatment plan was assessed in participants currently being treated in the Full Analysis Set. Participants may have been included in more than one category. | Posted | Count of Participants | Participants | Baseline up to end of observation period (approximately 2 years) |
|
|
|
| Primary | Number of Participants Based on Tumor Severity Classification at Baseline Based on MRI in Patients With Diffuse TGCT (d-TGCT) | Tumor severity classification was collected from information routinely recorded in the patient files / medical records. ). Tumor severity classification was based on MRI. In this classification scheme, moderate diffuse TGCT is characterized by intra- and/or extra-articular disease, without or with involvement of muscle/tendinous tissue/ligaments. Severe diffuse TGCT is characterized by intra- and extra-articular involvement and involvement of at least one of the 3 structures (muscle/tendinous tissue/ligaments). | Tumor severity was assessed in participants in the Full Analysis Set. | Posted | Count of Participants | Participants | at Baseline |
|
|
|
| Primary | Number of Cases With Complications Due to Surgery in Patients With Diffuse TGCT (d-TGCT) | Complications due to surgery were collected from information routinely recorded in the patient files / medical records. | Complications were assessed among participants with documented surgeries. | Posted | Number | surgical cases | at Baseline (prior to any d-TGCT therapy) | Surgeries | Surgeries |
|
|
|
| Primary | Number of Participants With Tumor Recurrence at Baseline in Patients With Diffuse TGCT (d-TGCT) | Tumor recurrence was collected from information routinely recorded in the patient files / medical records. | Tumor recurrence was assessed in participants with available baseline data in the Full Analysis Set. | Posted | Count of Participants | Participants | at Baseline |
|
|
|
| Primary | Time Since Most Recent Tumor Recurrence Until Baseline in Patients With Diffuse TGCT (d-TGCT) | Time since most recent tumor recurrence was collected from information routinely recorded in the patient files / medical records. | Time since last recent tumor recurrence until baseline was assessed in participants with available baseline data in the Full Analysis Set. | Posted | Median | Full Range | months | at Baseline |
|
|
|
| Primary | Time From Baseline to First Tumor Recurrence in Patients With Diffuse TGCT (d-TGCT) | Time from baseline to first tumor recurrence was collected from information routinely recorded in the patient files / medical records. | Time from baseline to first tumor recurrence was assessed in participants with available data in the Full Analysis Set. | Posted | Median | Full Range | months | Baseline up to end of observation period (approximately 2 years) |
|
|
|
| Primary | Mean Brief Pain Inventory (BPI) Pain Severity and Interference Score From Baseline Through 24 Months | The BPI short form is a self administered questionnaire that assesses severity of pain, impact of pain on daily function, location of pain, pain medications and amount of pain relief in the past 24 hours or the past week. The BPI pain severity and interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes), where lower scores indicate better clinical outcome. | Brief Pain Inventory Pain Severity and Pain Interference were assessed in participants with available data in the Full Analysis Set. | Posted | Mean | Standard Deviation | score on a scale | Baseline up to end of observation period (approximately 2 years) |
|
|
|
| Primary | Mean Worst Stiffness Score From Baseline Through 24 Months | The Worst Stiffness numerical rating scale (NRS) is a one-item self-administered, patient-reported outcome questionnaire assessing the "worst" stiffness in the last 24 hours. The NRS for this item ranges from 0 ("no stiffness") to 10 ("stiffness as bad as you can imagine"), where lower scores indicate better clinical outcome. | Worst stiffness was assessed in participants with available data in the Full Analysis Set. | Posted | Mean | Standard Deviation | score on a scale | Baseline up to end of observation period (approximately 2 years) |
|
|
|
| Primary | Mean PROMIS Physical Function Score From Baseline Through 24 Months | PROMIS® (Patient-Reported Outcomes Measurement Information System) is a set of person-centered measures that evaluates and monitors physical, mental, and social health. Physical function scores range from 0 (worst physical function) to 100 (best physical function, where higher scores indicate better clinical outcome. | PROMIS physical function was assessed in participants with available data in the Full Analysis Set. | Posted | Mean | Standard Deviation | score on a scale | Baseline up to end of observation period (approximately 2 years) |
|
|
|
| Secondary | Mean EuroQol Questionnaire (EQ) of 5 Dimensions (5D) Index Score and EQ Visual Analog Scale Score From Baseline Through 24 Months | The EQ-5D-5L questionnaire measures the patient's quality of life (QoL) based on the 5 dimensions mobility, self care, usual activities, pain/discomfort, and anxiety/depression. The EQ-5D index score ranges from 0 (worst QoL) to 1 (best QoL), where lower scores indicate worse clinical outcome. The EQ-5D VAS reports patient's self rated health ranging from 0 (worst health) to 100 (best health you can imagine), where lower scores indicate worse clinical outcome. | Quality of life assessed by EQ-5D index score was assessed in participants with available data in the Full Analysis Set. | Posted | Mean | Standard Deviation | score on a scale | Baseline up to end of observation period (approximately 2 years) |
|
|
|
| Secondary | Mean Number of General Practitioner, Specialist, or Physical Therapy Visits to Assess the Health Resource Utilization in Patients With Diffuse TGCT Through 24 Months | Health resource utilization was assessed by mean number of general practitioner visits, specialist visits, and physical therapy sessions. In addition, the mean number of days in rehabilitation and the number of work days missed were also reported. | Health resource utilization was assessed in participants with available data in the Full Analysis Set. | Posted | Mean | Standard Deviation | visits | 13-24 months before baseline up to end of observation period (approximately 2 years) |
|
|
|
| Secondary | Median Number of Days in Rehabilitation and Work Days Missed in Patients With Diffuse TGCT Through 24 Months | The median number of days in rehabilitation and the number of work days missed were also reported. | Number of days in rehabilitation was assessed in the Full Analysis Set. A participant could have documented days in rehabilitation for the 1st year visit as well as for the 2nd year visit which resulted in a sum greater than the single results per visit/year. | Posted | Median | Full Range | days | 13-24 months before baseline up to end of observation period (approximately 2 years) |
|
|
|
| Secondary | Overall TGCT Outcome Status in Patients With Diffuse TGCT (d-TGCT) | TGCT outcome status was collected from information routinely recorded in the patient files / medical records. | TGCT outcome status was assessed in participants with available data in the Full Analysis Set. | Posted | Count of Participants | Participants | At end of observation period (approximately 2 years post-baseline) |
|
|
|
| 1 |
| 183 |
| 0 |
| 0 |
| 0 |
| 0 |
Not provided
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| D000070779 | Giant Cell Tumor of Tendon Sheath |
| D013585 | Synovitis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D052256 | Tendinopathy |
| D009135 | Muscular Diseases |
|
| Unknown/Missing |
|
| Title | Measurements |
|---|---|
|
| Systemic therapy |
|
| Surgery |
|
| Future surgery required |
|
| No current or planned treatment |
|
| Unchanged therapy |
|
| Title | Measurements |
|---|---|
|
| Missing |
|
| Title | Measurements |
|---|---|
|
| Surgery |
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Missing |
|
|
| Brief Pain Inventory Pain Interference |
|
|
|
| EQ-5D VAS |
|
|
| Specialists visits |
|
| Physical therapy sessions |
|
| Work days missed |
|
|
| TCGT status at end of observational period: Radiological recurrent disease |
|
|
| TCGT status at end of observational period: Missing |
|
|
| NED (only pts with NED): With complaints |
|
|
| NED (only pts with NED): Without complaints |
|
|
| NED (only pts with NED): Missing |
|
|
| Radiological residual disease (only pts with radiological residual disease): Watchful waiting |
|
|
| Radiological residual disease (only pts with radiological residual disease): Awaiting surgery |
|
|
| Radiological residual disease (only pts with radiological residual disease): Awaiting medication |
|
|
| Radiological residual disease (only pts with radiological residual disease):Awaiting other treatment |
|
|
| Radiological residual disease (only pts with radiological residual disease): Missing |
|
|
| Radiological recurrent disease (only pts with radiological recurrent disease): Watchful waiting |
|
|
| Radiological recurrent disease (only pts with radiological recurrent disease): Awaiting surgery |
|
|
| Radiological recurrent disease (only pts with radiological recurrent disease): Awaiting medication |
|
|
| Radiological recurrent disease (only pts with radiological recurrent): Awaiting other treatment |
|
|
| Radiological recurrent disease (only pts with radiological recurrent disease): Missing |
|
|