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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2013-00530 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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This clinical trial studies lymph node mapping in patients with endometrial cancer. Lymph node mapping may allow for limited removal of lymph nodes in as part of endometrial cancer staging and treatment.
PRIMARY OBJECTIVE:
I. To estimate the negative predictive value of pelvic sentinel lymph node (SLN) in endometrial cancer to predict nodal metastasis.
SECONDARY OBJECTIVE:
II. To examine the ability of sentinel lymph nodes to increase the detection of metastatic disease through ultra-sectioning and immuno-histochemical (IHC) staining by comparing IHC results and standard hematoxylin and eosin (H&E) results.
OUTLINE:
Patients undergo sentinel lymph node detection using fluorescence imaging with indocyanine green solution and isosulfan blue and sentinel lymph node biopsy and detection of sentinel lymph nodes is noted in the within 30 minutes of injection of the dye, followed by full pelvic lymph node dissection and aortic lymph node dissection as indicated, and standard hysterectomy and salpingo-oophorectomy.
After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 3 years for a total of 5 years according to the standard surveillance guidelines for endometrial cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| sentinel lymph node detection | Experimental | Patients undergo sentinel lymph node detection using fluorescence imaging with indocyanine green solution and isosulfan blue and sentinel lymph node biopsy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sentinel lymph node detection | Procedure | Undergo sentinel lymph node detection using fluorescence imaging with indocyanine green solution and isosulfan blue |
|
| Measure | Description | Time Frame |
|---|---|---|
| Negative Predictive Value of Sentinel Lymph Node Prediction of Metastatic Disease | NPV is found by dividing the number of true negatives by the number of all patients without pelvic lymph node metastases. Exact 95% confidence intervals (CIs) for the proportions will be calculated. | average of 1-14 days after the procedure when final pathologic evaluation has been completed |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Metastatic Cases Found Using Ultra-sectioning and IHC Staining | The percentage of metastatic cases analyzed by H&E will be compared to those of H&E-plus- IHC/ultrastaging using a "z-test". | average of 1-14 days after the procedure when final pathologic evalulation has been completed |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Floor Backes, MD | Ohio State University Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Smilow Cancer Hospital at Yale New Haven | New Haven | Connecticut | 06520 | United States | ||
| Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31230614 | Background | Backes FJ, Cohen D, Salani R, Cohn DE, O'Malley DM, Fanning E, Suarez AA, Fowler JM. Prospective clinical trial of robotic sentinel lymph node assessment with isosulfane blue (ISB) and indocyanine green (ICG) in endometrial cancer and the impact of ultrastaging (NCT01818739). Gynecol Oncol. 2019 Jun;153(3):496-499. doi: 10.1016/j.ygyno.2019.03.252. Epub 2019 Apr 4. |
| Label | URL |
|---|---|
| The Jamesline | View source |
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The study opened in February 2013 and patients were enrolled between March 2013 and November 2016
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| ID | Title | Description |
|---|---|---|
| FG000 | Sentinel Lymph Node Detection | Patients undergo sentinel lymph node detection using fluorescence imaging with indocyanine green solution and isosulfan blue and sentinel lymph node biopsy. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Patients received dye injections
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| ID | Title | Description |
|---|---|---|
| BG000 | Sentinel Lymph Node Detection | Patients undergo sentinel lymph node detection using fluorescence imaging with indocyanine green solution and isosulfan blue and sentinel lymph node biopsy. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Negative Predictive Value of Sentinel Lymph Node Prediction of Metastatic Disease | NPV is found by dividing the number of true negatives by the number of all patients without pelvic lymph node metastases. Exact 95% confidence intervals (CIs) for the proportions will be calculated. | Posted | Number | 95% Confidence Interval | percentage of patients | average of 1-14 days after the procedure when final pathologic evaluation has been completed |
|
|
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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 | Sentinel Lymph Node Detection | Patients undergo sentinel lymph node detection using fluorescence imaging with indocyanine green solution and isosulfan blue and sentinel lymph node biopsy. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Floor Backes, MD | The Ohio State University Comprehensive Cancer Center | 614-730-6968 | Floor.Backes@osumc.edu |
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| ID | Term |
|---|---|
| D016889 | Endometrial Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D007208 | Indocyanine Green |
| C025484 | iso-sulfan blue |
| D021701 | Sentinel Lymph Node Biopsy |
| ID | Term |
|---|---|
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| indocyanine green solution | Drug | Undergo sentinel lymph node detection using fluorescence imaging with indocyanine green solution and isosulfan blue |
|
|
| isosulfan blue | Drug | Undergo sentinel lymph node detection using fluorescence imaging with indocyanine green solution and isosulfan blue |
|
|
| sentinel lymph node biopsy | Procedure | Undergo sentinel lymph node biopsy |
|
|
| Columbus |
| Ohio |
| 43210 |
| United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index (BMI) | Median | Full Range | kg/m^2 |
|
| Participants |
|
|
| Secondary | Percentage of Metastatic Cases Found Using Ultra-sectioning and IHC Staining | The percentage of metastatic cases analyzed by H&E will be compared to those of H&E-plus- IHC/ultrastaging using a "z-test". | Posted | Number | percentage of patients with positive LN | average of 1-14 days after the procedure when final pathologic evalulation has been completed |
|
|
|
| 0 |
| 204 |
| 0 |
| 204 |
| 0 |
| 204 |
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| 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 |
| 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 |
| D008197 | Lymph Node Excision |
| D008919 | Investigative Techniques |