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Impact of Sentinel Lymph Node Mapping on Patient Reported Lower Extremity Limb Dysfunction in Stage I Endometrial Cancer

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial sites expanded: 55 → 60 locationsv11
  2. Study sites: 54 to 55 Eligibility criteria shortened, about 37 words · Secondary endpoints: 5 to 4v10 Show 2 more changesShow less
    • Eligibility criteria shortened, about 37 words
    • Secondary endpoints: 5 to 4

    See this version in full on ClinicalTrials.gov ↗

  3. Primary completion date: Oct 31, 2025 to Oct 31, 2026 Study sites: 52 to 54v9 Show 1 more changeShow less
    • Study sites: 52 to 54
  4. Study sites: 41 to 52 Interventions: Biospecimen Collection (Procedure), Diagnostic Imaging (Procedure), Excisional Biopsy (Procedure), Indocyanine Green Solution (Drug)… to Biospecimen Collection (Procedure), Diagnostic Imaging Testing (Procedure), Excisional Biopsy (Procedure), Indocyanine Green Solution…v8 Show 1 more changeShow less
    • Interventions: Biospecimen Collection (Procedure), Diagnostic Imaging (Procedure), Excisional Biopsy (Procedure), Indocyanine Green Solution (Drug)… to Biospecimen Collection (Procedure), Diagnostic Imaging Testing (Procedure), Excisional Biopsy (Procedure), Indocyanine Green Solution…
  5. Study sites: 37 to 41 Interventions: Diagnostic Imaging (Procedure), Indocyanine Green Solution (Drug), Minimally Invasive Surgery (Procedure), Pelvic Lymphadenectomy… to Biospecimen Collection (Procedure), Diagnostic Imaging (Procedure), Excisional Biopsy (Procedure), Indocyanine Green Solution (Drug)… · Study description expanded, about 18 wordsv7 Show 2 more changesShow less
    • Interventions: Diagnostic Imaging (Procedure), Indocyanine Green Solution (Drug), Minimally Invasive Surgery (Procedure), Pelvic Lymphadenectomy… to Biospecimen Collection (Procedure), Diagnostic Imaging (Procedure), Excisional Biopsy (Procedure), Indocyanine Green Solution (Drug)…
    • Study description expanded, about 18 words

    See this version in full on ClinicalTrials.gov ↗

Show 5 earlier versionsHide 5 earlier versions
  1. Study sites: 36 to 37v6
  2. Site contacts updated at 2 of 36 sitesv5
  3. Study sites: 8 to 36 Interventions: Indocyanine Green Solution (Drug), Minimally Invasive Surgery (Procedure), Pelvic Lymphadenectomy (Procedure), Questionnaire Administration… to Diagnostic Imaging (Procedure), Indocyanine Green Solution (Drug), Minimally Invasive Surgery (Procedure), Pelvic Lymphadenectomy…v4 Show 1 more changeShow less
    • Interventions: Indocyanine Green Solution (Drug), Minimally Invasive Surgery (Procedure), Pelvic Lymphadenectomy (Procedure), Questionnaire Administration… to Diagnostic Imaging (Procedure), Indocyanine Green Solution (Drug), Minimally Invasive Surgery (Procedure), Pelvic Lymphadenectomy…
  4. Start date: Sep 19, 2022 to Dec 7, 2022 Study sites: 1 to 8 · Primary completion date: Jul 1, 2026 to Oct 31, 2025 · Completion date: Jul 1, 2027 to Oct 31, 2026 · 3 morev3 Show 6 more changesShow less
    • Study sites: 1 to 8
    • Primary completion date: Jul 1, 2026 to Oct 31, 2025
    • Completion date: Jul 1, 2027 to Oct 31, 2026
    • Secondary endpoints: 2 to 5
    • Study description expanded, about 11 words
    • Eligibility criteria shortened, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  5. Re-verified, no change to tracked fieldsv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
NRG Oncology
67 trials monitored
See 5 trials at risk
Sarcoma
951 trials monitored
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Endometrial Cancer
633 trials monitored
See 40 trials at risk
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.
Trial Details
NCT Number NCT05646316
Lead Sponsor NRG Oncology
Collaborators: National Cancer Institute (NCI)
Conditions Stage I Uterine Corpus Carcinoma or Carcinosarcoma AJCC v8
Enrollment 428 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov