NCT06689956 Outcomes of Low-Risk Endometrial Cancer With Isolated Tumor Cells in the Sentinel Lymph Nodes: A Prospective, Multicenter, Single-Arm Observational Study
| NCT ID | NCT06689956 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Mayo Clinic |
| Condition | FIGO Grade 1 Endometrial Endometrioid Adenocarcinoma |
| Study Type | OBSERVATIONAL |
| Enrollment | 212 participants |
| Start Date | 2024-12-04 |
| Primary Completion | 2029-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 212 participants in total. It began in 2024-12-04 with a primary completion date of 2029-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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).
Contact & Investigator
Gretchen E. Glaser, MD
PRINCIPAL INVESTIGATOR
Mayo Clinic in Rochester
Frequently Asked Questions
Who can join the NCT06689956 clinical trial?
This trial is open to participants of all sexes, studying FIGO Grade 1 Endometrial Endometrioid Adenocarcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06689956 currently recruiting?
Yes, NCT06689956 is actively recruiting participants. Contact the research team at mayocliniccancerstudies@mayo.edu for enrollment information.
Where is the NCT06689956 trial being conducted?
This trial is being conducted at Rochester, United States, New York, United States, Houston, United States, Vienna, Austria and 11 additional locations.
Who is sponsoring the NCT06689956 clinical trial?
NCT06689956 is sponsored by Mayo Clinic. The principal investigator is Gretchen E. Glaser, MD at Mayo Clinic in Rochester. The trial plans to enroll 212 participants.