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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2013-01309 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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Slow Accrual
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This clinical trial studies lymph node mapping in patients with newly diagnosed endometrial cancer undergoing surgery. Lymph node mapping may help in planning surgery to remove endometrial cancer and affected lymph nodes.
PRIMARY OBJECTIVES:
I. To determine the detection rate, sensitivity, and negative predictive value of sentinel lymph node (SLN) biopsy in endometrial cancer patients.
SECONDARY OBJECTIVES:
I. To compare different surgical modalities (open procedures, minimally invasive procedures, and single-site technology) and different injectants (isosulfan blue and indocyanine green) for SLN biopsy.
II. To determine total operating room time (from the time the patient enters the room to the time the patient leaves the room) as well as console time (robotic)/operating time for minimally invasive procedures.
OUTLINE:
Patients undergo SLN mapping using isosulfan blue and/or indocyanine green solution injected directly into the cervix. Following SLN identification and biopsy, patients undergo hysterectomy, bilateral salpingo-oophorectomy, and/or complete pelvic lymphadenectomy. Patients expressing SLN positive for metastasis undergo para-aortic lymphadenectomy.
After completion of study treatment, patients are followed up at 2-4 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diagnostic (SLN mapping, biopsy, surgery) | Experimental | Patients undergo SLN mapping using isosulfan blue and/or indocyanine green solution injected directly into the cervix. Following SLN identification and biopsy, patients undergo hysterectomy, bilateral salpingo-oophorectomy, and/or complete pelvic lymphadenectomy. Patients expressing SLN positive for metastasis undergo para-aortic lymphadenectomy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lymph node mapping | Procedure | Undergo lymph node mapping using isosulfan blue and/or indocyanine green solution |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity of Sentential Lymph Node (SLN) Biopsy | Sensitivity estimated as the proportion of true positives among participants with lymph node metastases. Sensitivity Calculation= the number of patients with a positive SLN over those patients with a positive SLN plus those patients with a false negative lymph node. | Up to 4 weeks |
| Number of Participants in Whom a SLN is Detected | Detection Rate as defined by number of participants in whom a SLN is detected | Up to 4 weeks |
| Percent of Hemipelvises Identified With SLN | Detection rate, as defined by percent of hemipelvises identified with SLN | Up to 4 weeks |
| Number of Participants With Sentinel Nodes Per Side of Pelvis | Detection rate, as defined as number of participants with a sentinel node found per side of pelvis | Up to 4 weeks |
| False Negative Rate as Defined as Proportion of Participants With False Negative Detection | False negative rate = 1-sensitivity or the number of patients with a false negative SLN over the number of patients with a positive SLN plus those with a false negative lymph node | Up to 4 weeks |
| Percent of True Positive SLN Identified With Surgical Modalities (Open Procedures, Minimally Invasive Procedures, and Single-site Technology) | The percent of true positive SLN identified with surgical modalities using pairwise comparisons for each surgical modality. Comparisons will be performed using two sample tests of proportions based on a normal approximation. |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of True Positive SLNs Using Isosulfan Blue and Indocyanine Green Solution | Percent of true positive SLN identified will be compared between injectants utilized using a two sample test of proportions based on a normal approximation. Comparisons will be performed using two sample tests of proportions based on a normal approximation. | Up to 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chad Michener, MD | Case Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center | Cleveland | Ohio | 44195 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Diagnostic (SLN Mapping, Biopsy, Surgery) | Patients undergo SLN mapping using isosulfan blue and/or indocyanine green solution injected directly into the cervix. Following SLN identification and biopsy, patients undergo hysterectomy, bilateral salpingo-oophorectomy, and/or complete pelvic lymphadenectomy. Patients expressing SLN positive for metastasis undergo para-aortic lymphadenectomy. lymph node mapping: Undergo lymph node mapping using isosulfan blue and/or indocyanine green solution sentinel lymph node biopsy: Undergo SLN biopsy isosulfan blue: Undergo lymph node mapping using isosulfan blue and/or indocyanine green solution indocyanine green solution: Undergo lymph node mapping using isosulfan blue and/or indocyanine green solution therapeutic conventional surgery: Undergo hysterectomy, bilateral salpingo-oophorectomy and/or complete pelvic lymphadenectomy lymphadenectomy: Undergo para-aortic lymphadenectomy |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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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 | Aug 2, 2013 |
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| sentinel lymph node biopsy | Procedure | Undergo SLN biopsy |
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| isosulfan blue | Drug | Undergo lymph node mapping using isosulfan blue and/or indocyanine green solution |
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| indocyanine green solution | Drug | Undergo lymph node mapping using isosulfan blue and/or indocyanine green solution |
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| therapeutic conventional surgery | Procedure | Undergo hysterectomy, bilateral salpingo-oophorectomy and/or complete pelvic lymphadenectomy |
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| lymphadenectomy | Procedure | Undergo para-aortic lymphadenectomy |
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| Up to 4 weeks |
| Total Operating Room Time in Minutes | Total operating room time will be estimated as a mean with 95% confidence interval if the data have an approximately normal distribution. Otherwise, the median and a bootstrapped 95% confidence interval for the median will be reported. Similar summaries will be provided for the console time (robotic)/ operating time. | From the time the patient enters the room to the time the patient leaves the room, assessed up to 4 weeks |
| COMPLETED |
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| NOT COMPLETED |
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Evaluable participants who completed study
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| ID | Title | Description |
|---|---|---|
| BG000 | Diagnostic (SLN Mapping, Biopsy, Surgery) | Patients undergo SLN mapping using isosulfan blue and/or indocyanine green solution injected directly into the cervix. Following SLN identification and biopsy, patients undergo hysterectomy, bilateral salpingo-oophorectomy, and/or complete pelvic lymphadenectomy. Patients expressing SLN positive for metastasis undergo para-aortic lymphadenectomy. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants | Participants |
| ||||||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | Sensitivity of Sentential Lymph Node (SLN) Biopsy | Sensitivity estimated as the proportion of true positives among participants with lymph node metastases. Sensitivity Calculation= the number of patients with a positive SLN over those patients with a positive SLN plus those patients with a false negative lymph node. | Participants with with lymph node metastases | Posted | Number | percent | Up to 4 weeks |
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| ||||||||||||||||||||||||||
| Primary | Number of Participants in Whom a SLN is Detected | Detection Rate as defined by number of participants in whom a SLN is detected | Participants who completed study | Posted | Count of Participants | Participants | Up to 4 weeks |
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| Primary | Percent of Hemipelvises Identified With SLN | Detection rate, as defined by percent of hemipelvises identified with SLN | Participants who completed study | Posted | Number | Percent of Hemipelvises | Up to 4 weeks |
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| Primary | Number of Participants With Sentinel Nodes Per Side of Pelvis | Detection rate, as defined as number of participants with a sentinel node found per side of pelvis | Participants who completed study | Posted | Number | participants | Up to 4 weeks |
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| Primary | False Negative Rate as Defined as Proportion of Participants With False Negative Detection | False negative rate = 1-sensitivity or the number of patients with a false negative SLN over the number of patients with a positive SLN plus those with a false negative lymph node | Participants who completed study | Posted | Number | Proportion of participants | Up to 4 weeks |
|
| |||||||||||||||||||||||||||
| Primary | Percent of True Positive SLN Identified With Surgical Modalities (Open Procedures, Minimally Invasive Procedures, and Single-site Technology) | The percent of true positive SLN identified with surgical modalities using pairwise comparisons for each surgical modality. Comparisons will be performed using two sample tests of proportions based on a normal approximation. | Participants who completed study | Posted | Number | percentage of true positive SNLs | Up to 4 weeks |
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| Secondary | Percent of True Positive SLNs Using Isosulfan Blue and Indocyanine Green Solution | Percent of true positive SLN identified will be compared between injectants utilized using a two sample test of proportions based on a normal approximation. Comparisons will be performed using two sample tests of proportions based on a normal approximation. | Participants who completed study | Posted | Number | Percentage of true positive SLNs | Up to 4 weeks |
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| Secondary | Total Operating Room Time in Minutes | Total operating room time will be estimated as a mean with 95% confidence interval if the data have an approximately normal distribution. Otherwise, the median and a bootstrapped 95% confidence interval for the median will be reported. Similar summaries will be provided for the console time (robotic)/ operating time. | Participants who completed study | Posted | Median | 95% Confidence Interval | minutes | From the time the patient enters the room to the time the patient leaves the room, assessed up to 4 weeks |
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Up to 30 days from last treatment dose
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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 | Diagnostic (SLN Mapping, Biopsy, Surgery) | Patients undergo SLN mapping using isosulfan blue and/or indocyanine green solution injected directly into the cervix. Following SLN identification and biopsy, patients undergo hysterectomy, bilateral salpingo-oophorectomy, and/or complete pelvic lymphadenectomy. Patients expressing SLN positive for metastasis undergo para-aortic lymphadenectomy. | 0 | 58 | 0 | 58 | 1 | 58 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| New onset atrial fibrillation | Cardiac disorders | CTCAE v4.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Chad Michener | University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center | 216-444-6601 | michenc@ccf.org |
| Jul 7, 2020 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 21, 2016 | Jul 22, 2020 | ICF_001.pdf |
| ID | Term |
|---|---|
| D016889 | Endometrial Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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| ID | Term |
|---|---|
| D021701 | Sentinel Lymph Node Biopsy |
| C025484 | iso-sulfan blue |
| D007208 | Indocyanine Green |
| D008197 | Lymph Node Excision |
| ID | Term |
|---|---|
| D001706 | Biopsy |
| D003581 | Cytodiagnosis |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D013048 | Specimen Handling |
| D003949 | Diagnostic Techniques, Surgical |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Title | Measurements |
|---|---|
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| 50-59 years |
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| 60-69 years |
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| 70-79 years |
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| 80-89 years |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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