ctDNA Testing to Inform Standard-of-Care Treatment Decisions in People With Endometrial Cancer
Part of paid clinical trials in Basking Ridge, New Jersey.
- Sponsor
- Memorial Sloan Kettering Cancer Center
- Study ID
- NCT07270666
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- FEMALE
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- ctDNA Testing — GENETICPatients will undergo ctDNA sampling at the 1-year timepoint using the commercially available Natera SignateraTM test.
- Blood draw — OTHERat the 1-year timepoint
Study Details
The researchers are doing this study to evaluate the use of circulating tumor DNA (ctDNA) testing in making treatment decisions for advanced/recurrent endometrial cancer that has a change (mutation) in the mismatch repair deficient (MMR-D) gene or microsatellite instability high (MSI-H) gene. The researchers will see how doctors and their patients use the results of ctDNA testing after 1 year of standard chemotherapy and immune checkpoint inhibitor (ICI) treatment to decide whether to continue maintenance ICI treatment past 1 year. The researchers will also look at the health outcomes of people in this study (for example, whether they are cancer free at the end of their participation in the study).
Key Dates
- Start date
- Nov 25, 2025
- Status verified
- Dec 2025
- Primary completion
- Nov 30, 2027
- Completion
- Nov 30, 2027
Study Design
- Enrollment
- 30 participants (estimated)
- Allocation
- NON_RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: ctDNA-negative groupParticipants in this group will have negative ctDNA test results at 1 year after they start standard treatment. (Negative results indicate that no cancer DNA is detected in their blood.) Participants in this group will decide with their doctor if they want to stop standard maintenance ICI treatment.
- Experimental: ctDNA-positive groupParticipants in this group will have positive ctDNA test results at 1 year after they start standard treatment. (Positive results indicate that cancer DNA is detected in their blood.) Participants in this group will continue receiving standard treatment with their doctor.
Primary Outcome Measure
will test the feasibility of ct-DNA [ Time Frame: 1 year ]
Central Contacts
- Ying Liu, MD, MPH646-888-4946
- Paul Johannet, MD646-888-5327
Locations (7)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Memorial Sloan Kettering Basking Ridge (All Protocol Activites) | Basking Ridge | New Jersey | 07920 | Ying Liu, MD 646-888-4946 |
| Memorial Sloan Kettering Monmouth (All Protocol Activities) | Middletown | New Jersey | 07748 | Ying Liu, MD 646-888-4946 |
| Memorial Sloan Kettering Bergen (All Protocol Activities) | Montvale | New Jersey | 07645 | Ying Liu, MD 646-888-4946 |
| Memorial Sloan Kettering Suffolk - Commack (All Protocol Activities) | Commack | New York | 11725 | Ying Liu, MD 646-888-4946 |
| Memorial Sloan Kettering Westchester (All Protocol Activities) | Harrison | New York | 10604 | Ying Lui, MD 646-888-4946 |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | Ying Liu, MD, MPH. 646-888-4946 Roisin O'Cearbhaill, MD 646-888-4227 |
| Memorial Sloan Kettering Nassau (All Protocol Activities) | Rockville Centre | New York | 11570 | Ying Liu, MD 646-888-4946 |
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