Endometrial Cancer Clinical Trial
— EndoSLNOfficial title:
Accuracy of Sentinel Lymph Node Biopsy in Nodal Staging of High Risk Endometrial Cancer: A Prospective Trial
NCT number | NCT01886066 |
Other study ID # | 12-0257-C |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | March 2012 |
Est. completion date | September 2021 |
Verified date | March 2024 |
Source | University Health Network, Toronto |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The standard of care for women with high risk endometrial cancer is the removal of all visible lymph nodes in the pelvis and lower abdomen to identify if disease has spread to these areas. It is estimated that no more than 25% of all women with presumed early stage high risk endometrial cancer will have positive lymph nodes however currently the majority of women are subjected to extensive resection of all pelvic lymph and or para-aortic lymph nodes and its associated morbidities. The objective of this study is to determine if intraoperative sentinel lymph node (SLN) mapping will improve the assessment of regional lymph nodes and enhance the detection of lymph nodes with metastatic disease in endometrial cancer. This would benefit the majority of women with early stage high risk endometrial cancer and would prevent the associated complications of pelvic lymph node dissection.
Status | Completed |
Enrollment | 156 |
Est. completion date | September 2021 |
Est. primary completion date | June 21, 2019 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Women with endometrial cancer with high risk histologic subtypes including grade 3 endometrioid, carcinosarcoma, serous, clear cell, undifferentiated adenocarcinoma, and and any mixed high risk histology. - Clinical stage 1 disease- no evidence of metastatic disease beyond the uterus by physical exam or preoperative imaging if performed. - Patients who have signed an approved informed consent. - Patients who will undergo surgery that includes a hysterectomy and bilateral pelvic and inframesenteric para-aortic lymphadenectomy via laparoscopy or robotic-assisted. Exclusion Criteria: - Women with grade 1 or 2 endometrioid adenocarcinoma - Patients with evidence of metastatic disease on preoperative imaging. - Patients with evidence of intraperitoneal metastatic disease intraoperatively (patients with suspicious retroperitoneal lymph nodes intraoperatively will still be included). - Patients with known allergy to iodine compounds - Pregnant patient. - Patients with previous retroperitoneal surgery. - Patients with previous history of pelvic/abdominal radiation. - Patients with recurrent endometrial cancer. - Any patient treated with neoadjuvant chemotherapy and/or radiation. |
Country | Name | City | State |
---|---|---|---|
Canada | Sunnybrook Health Sciences Center | Toronto | Ontario |
Canada | University Health Network - Princess Margaret Hospital | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
University Health Network, Toronto |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Performance Analysis | Performance analyses of SLN mapping will be performed. In particular, sensitivity, specificity, and predictive accuracy of mapping and detection of sentinel lymph nodes with metastatic disease will be calculated using the pathology results of the surgical intervention as the Standard of Reference. Performance analyses will be evaluated at both the lesion and patient level. Generalized estimating equations will be used to adjust for correlations of repeated measures within patients. Raw performance estimates will be reported with adjusted 95% confidence intervals. | Year 3 |
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