About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients must have pathologically confirmed endometrial cancer
Patients with advanced endometrial cancer
Stage III with residual disease
Stage IV
Disqualifiers
None
Trial design
Parallel
Treatments tested in this trial
ctDNA Testing
GeneticPatients will undergo ctDNA sampling at the 1-year timepoint using the commercially available Natera SignateraTM test.
Blood draw
Other interventionat the 1-year timepoint
Surveys
Other interventionPatients 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
Other interventionWill 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.
Treatment groups
Trial outcomes
Primary outcomes
will test the feasibility of ct-DNA
informed de-escalation of standard of care ICI maintenance therapy defined as willingness of patients/providers to stop ICI therapy after 1 year in those with negative ctDNA testing.
Sponsors and contacts
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