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ctDNA Testing to Inform Standard-of-Care Treatment Decisions in People With Endometrial Cancer
Sponsor: Memorial Sloan Kettering Cancer Center
Summary
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).
Official title: Pragmatic Pilot Study of ctDNA Informed Immune Checkpoint Inhibitor De-escalation in Advanced/Recurrent Mismatch Repair Deficient (MMR-D)/Microsatellite Instability High (MSI-H) Endometrial Cancer Using Standard of Care Treatments
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2025-11-25
Completion Date
2027-11
Last Updated
2026-07-13
Healthy Volunteers
No
Conditions
Interventions
ctDNA Testing
Patients will undergo ctDNA sampling at the 1-year timepoint using the commercially available Natera SignateraTM test.
Blood draw
at the 1-year timepoint
Surveys
Patients and providers will also complete surveys at various timepoints to evaluate distress, shared decision-making, acceptability and other factors contributing to the decision-making process.
Semi-structured interviews
Will be performed within 6 months of receiving the 1-year clinical ctDNA result. Discussion via telephone or during a standard of care clinical visit (in person or telemedicine) with treating physician or team member within 28 days of clinical 1-year ctDNA result to discuss results with the patient and decide on de-escalation if applicable.
Locations (7)
Memorial Sloan Kettering Basking Ridge (All Protocol Activites)
Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Monmouth (All Protocol Activities)
Middletown, New Jersey, United States
Memorial Sloan Kettering Bergen (All Protocol Activities)
Montvale, New Jersey, United States
Memorial Sloan Kettering Suffolk - Commack (All Protocol Activities)
Commack, New York, United States
Memorial Sloan Kettering Westchester (All Protocol Activities)
Harrison, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Memorial Sloan Kettering Nassau (All Protocol Activities)
Rockville Centre, New York, United States