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Slow accrual
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This study aims to estimate the recurrence-free survival rates in women with endometrial cancer treated with selective versus sentinel node surgical staging.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sentinel Node Surgical Staging | Experimental |
| |
| Selective Surgical Staging | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sentinel node procedure | Procedure | Excision of ALL mapped nodes and other suspicious nodes regardless of mapping and label by anatomic location |
|
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence-free survival rate | Recurrence-free survival rate in women with endometrial cancer treated with selective versus sentinel node surgical staging | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival rate | Progress-free survival rate in women with endometrial cancer treated with selective versus sentinel node surgical staging | 5 years |
| Disease-specific survival rate |
| Measure | Description | Time Frame |
|---|---|---|
| Location patterns of nodal involvement associated with staging procedures | Location patterns related to nodal involvement with staging procedures will be reported. | 5 years |
| Number of metastatic lymph node(s) associated with staging procedures |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Frederick Ueland, MD | University of Kentucky | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kentucky | Lexington | Kentucky | 40506 | United States |
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| ID | Term |
|---|---|
| D016889 | Endometrial Neoplasms |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| Selective staging | Procedure | Intraoperative consultation (IOC) |
|
Disease-specific survival rate in women with endometrial cancer treated with selective versus sentinel node surgical staging
| 5 years |
| Overall patient survival rate | Overall survival rate in women with endometrial cancer treated with selective versus sentinel node surgical staging | 5 years |
| Concordance of SELECTIVE and SENTINEL NODE surgical staging with final pathology | Percentage of participants for whom selective surgical staging and final pathology match. Match incorporates grade, lesion size, depth of invasion, and low-risk (no lymphadenectomy) versus high-risk (lymphadenectomy). | 5 years |
| Patient morbidity | 5 years |
| Patient mortality | 5 years |
The number of metastatic lymph node(s) associated with the staging procedures will be reported.
| 5 years |
| Patterns of nodal involvement associated with primary tumor grade | Primary tumor grade related to nodal involvement will be reported | 5 years |
| Patterns of nodal involvement associated with primary tumor lesion size | Primary tumor lesion size related to nodal involvement will be reported. | 5 years |
| Patterns of nodal involvement associated with primary tumor depth of invasion | Primary tumor depth related to nodal involvement will be reported. | 5 years |
| Patterns of nodal involvement associated with primary tumor cell type | Primary tumor cell type related to nodal involvement will be reported. | 5 years |
| Location patterns of nodal involvement associated with disease stage | Location related to nodal involvement with disease stage will be reported. | 5 years |
| Number of metastatic lymph node(s) associated with disease stage | The number of metastatic lymph node(s) associated with the staging procedures will be reported. | 5 years |
| D014591 |
| Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |