Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05646316 · ClinicalTrials.gov registry record · Phase 3
Impact of Sentinel Lymph Node Mapping on Patient Reported Lower Extremity Limb Dysfunction in Stage I Endometrial Cancer
A Phase 3 study of Stage I Uterine Corpus Carcinoma or Carcinosarcoma AJCC v8, sponsored by NRG Oncology.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 428
- Enrollment target
- 20
- Study locations
NCT05646316 is a Phase 3 study of Stage I Uterine Corpus Carcinoma or Carcinosarcoma AJCC v8 that is actively recruiting participants, run by NRG Oncology. The registered enrollment target is 428 participants. The trial reports 20 study locations across 8 states.
The verdict
NCT05646316, a Phase 3 study of Stage I Uterine Corpus Carcinoma or Carcinosarcoma AJCC v8, is actively recruiting participants, sponsored by NRG Oncology.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 428 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase III trial compares the effect of sentinel lymph node mapping to standard lymph node dissection in reducing the risk of swelling in the legs (lymphedema) in patients undergoing a hysterectomy for stage I endometrial cancer. Standard lymph node dissection removes lymph nodes around the uterus during a hysterectomy to look for spread of cancer from the uterus to nearby lymph nodes. Sentinel lymph node mapping uses a special dye and camera to look for cancer that may have spread to nearby lymph nodes. Comparing the results of the procedures may help doctors predict the risk of long-term swelling in the legs.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Diagnostic Imaging Testing
- PROCEDURE Excisional Biopsy
- DRUG Indocyanine Green Solution
- PROCEDURE Minimally Invasive Surgery
Study Locations (20)
Florida
- UM Sylvester Comprehensive Cancer Center at Coral Gables - Coral Gables
- UM Sylvester Comprehensive Cancer Center at Deerfield Beach - Deerfield Beach
- UM Sylvester Comprehensive Cancer Center at Doral - Doral
- University of Miami Miller School of Medicine-Sylvester Cancer Center - Miami
- UM Sylvester Comprehensive Cancer Center at Kendall - Miami
- UM Sylvester Comprehensive Cancer Center at Plantation - Plantation
Louisiana
- West Jefferson Medical Center - Marrero
- East Jefferson General Hospital - Metairie
- LSU Healthcare Network / Metairie Multi-Specialty Clinic - Metairie
- Louisiana State University Health Science Center - New Orleans
- University Medical Center New Orleans - New Orleans
Illinois
- Northwestern University - Chicago
- Northwestern Medicine Cancer Center Warrenville - Warrenville
Indiana
- IU Health North Hospital - Carmel
- Indiana University/Melvin and Bren Simon Cancer Center - Indianapolis
Maryland
- University of Maryland/Greenebaum Cancer Center - Baltimore
- UM Upper Chesapeake Medical Center - Bel Air
District of Columbia
- George Washington University Medical Center - Washington D.C.
Georgia
- Augusta University Medical Center - Augusta
Michigan
- Wayne State University/Karmanos Cancer Institute - Detroit
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 428 participants |
| Start Date | 2022-12-07 |
| Est. Completion | 2026-10-31 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05646316
The ClinicalTrials.gov registry entry for NCT05646316 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 428 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NRG Oncology, which has 64 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Stage I Uterine Corpus Carcinoma or Carcinosarcoma AJCC v8 appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT05646316 reports 20 study locations spanning 8 distinct geographic areas - top geographies include Florida, Louisiana, Illinois.
Frequently Asked Questions
What is clinical trial NCT05646316 about?
NCT05646316 is a clinical study titled "Impact of Sentinel Lymph Node Mapping on Patient Reported Lower Extremity Limb Dysfunction in Stage I Endometrial Cancer". This phase III trial compares the effect of sentinel lymph node mapping to standard lymph node dissection in reducing the risk of swelling in the legs (lymphedema) in patients undergoing a hysterectomy for stage I endometrial cancer. Standard lymph node dissection removes lymph nodes around the uter...
What is the current status of trial NCT05646316?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 428 participants. The study started on 2022-12-07. Estimated completion is 2026-10-31.
What conditions does trial NCT05646316 study?
This clinical trial studies the following conditions: Stage I Uterine Corpus Carcinoma or Carcinosarcoma AJCC v8.
What interventions are being tested in trial NCT05646316?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Diagnostic Imaging Testing (PROCEDURE), Excisional Biopsy (PROCEDURE), Indocyanine Green Solution (DRUG), Minimally Invasive Surgery (PROCEDURE).
Who is sponsoring clinical trial NCT05646316?
This trial is sponsored by NRG Oncology, which has 64 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05646316 being conducted?
This trial has 20 study locations across District of Columbia, Florida, Georgia, Illinois, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Stage I Uterine Corpus Carcinoma or Carcinosarcoma AJCC v8
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.