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Impact of Sentinel Lymph Node Mapping on Patient Reported Lower Extremity Limb Dysfunction in Stage I Endometrial Cancer
NCT05646316 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. 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 162 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05646316 reports 20 study locations spanning 8 distinct geographic areas — top geographies include Florida, Louisiana, Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05646316?
This trial is sponsored by NRG Oncology, which has 162 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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