ctDNA Testing to Inform Standard-of-Care Treatment Decisions in People With Endometrial Cancer

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorMemorial Sloan Kettering Cancer Center

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 volunteers

Qualifiers

Patients must have pathologically confirmed endometrial cancer

Patients with advanced endometrial cancer

Stage III with residual disease

Stage IV

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • ctDNA Testing

    Genetic

    Patients will undergo ctDNA sampling at the 1-year timepoint using the commercially available Natera SignateraTM test.

  • Blood draw

    Other intervention

    at the 1-year timepoint

  • Surveys

    Other intervention

    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

    Other intervention

    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.

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: ctDNA-negative groupExperimental treatment 4 interventions
Group B: ctDNA-positive groupExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
1 year

Secondary outcomes

Other outcomes

Sponsors and contacts

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