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Following early uterine cancer with tiny cancer cells in nearby lymph nodes

Studies whether tiny cancer cells in lymph nodes near the uterus affect outlook.

Key facts

Who runs it
Mayo Clinic
Where
Toulouse, FranceSee the siteAlso in 9 other countries, 19 sites
Trial code
Registry title
Outcomes of Low-Risk Endometrial Cancer With Isolated Tumor Cells in the Sentinel Lymph Nodes: A Prospective, Multicenter, Single-Arm Observational Study
Status
Recruiting
People taking part
212 people, planned
Started
4 Dec 2024
Expected to end
31 Oct 2029
Type of study
Observational
Treatments tested
  • Non-Interventional Study
Record updated
19 February 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for people with low-risk endometrial (womb) cancer who had full surgery and have only tiny groups of tumor cells in the first lymph nodes near the tumor, and who need no treatment after surgery.

Sex
All sexes can join.
Disease stage
Low-risk endometrioid endometrial cancer, grade 1 or 2, FIGO 2009 stage IA (FIGO 2023 stages IA1 and IA2), without extensive LVSI (5 or more vessels involved). Focal LVSI (fewer than 5 vessels) is allowed. Only isolated tumor cells (≤ 0.2 mm or < 200 cells) in the sentinel lymph nodes.
Earlier treatment
Complete surgical staging with pelvic sentinel lymph node biopsy and ultrastaging. No treatment after surgery. No earlier chemotherapy before surgery.

Main reasons for not taking part

  • Earlier chemotherapy before surgery
  • Planned treatment after surgery
  • Another cancer at the same time (except non-melanoma skin cancer)
  • Larger tumor spread in the sentinel lymph nodes (micrometastasis or macrometastasis)
  • Extensive LVSI (5 or more vessels involved)

The registry criteria, word for word

Show all 2 criteriaShow less

Who can take part

  • Low-risk endometrial cancer, defined as endometrioid, grade 1 or 2, International Federation of Gynecology and Obstetrics (FIGO) 2009 stage IA (FIGO 2023 stages IA1 and IA2), without substantial/extensive LVSI (≥ 5 vessels involved) at final pathology. Patients with focal LVSI (< 5 vessels involved) will be included; Complete surgical staging, including pelvic sentinel lymph node (SLN) biopsy per National Comprehensive Cancer Network (NCCN) guidelines and ultrastaging; Extent of disease in SLN: ITC (defined as tumor cell aggregates ≤ 0.2 mm or < 200 cells); No adjuvant treatment after surgery; Research consent provided

Who cannot take part

  • Prior neoadjuvant chemotherapy; Planning to receive adjuvant treatment; Presence of synchronous cancer (excluding non-melanoma skin cancer); Extent of disease in SLN: micrometastasis (> 0.2 to ≤ 2.0 mm) or macrometastasis (> 2.0 mm); Presence of substantial/extensive LVSI (≥ 5 vessels involved) at final pathology; Prior invasive cancer diagnosis within 5 years of study entry (excluding non-melanoma skin cancer)

Where in France

Also in 9 other countries, 19 sites

  • Institut Universitaire du Cancer Toulouse - OncopoleToulouse, FranceContact: Alejandra MartinezNot yet recruiting

About the trial

What the trial wants to find out

This study evaluates whether isolated tumor cells in the first lymph nodes near the tumor can tell researchers something important about the future of patients with a certain type of endometrial (uterine) cancer.

The group in the trial

  • Observational

    Patients undergo tissue sample collection and have their medical records reviewed on study.

    Treatment: Non-Interventional Study

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Outcomes of Low-Risk Endometrial Cancer With Isolated Tumor Cells in the Sentinel Lymph Nodes: a Prospective Multicenter Single-Arm Observational Study
Plain-language title
Following early uterine cancer with tiny cancer cells in nearby lymph nodesGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
19 February 2026