ctDNA Testing
GeneticPatients will undergo ctDNA sampling at the 1-year timepoint using the commercially available Natera SignateraTM test.
NCT Number: NCT07270666
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).
Interested in participating?
Request Info18 year and older
Female
Interventional
Not applicable
Memorial Sloan Kettering Basking Ridge (All Protocol Activites), Basking Ridge, New Jersey, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
°Select patients with Stage III disease and no residual disease can be enrolled after discussion with PI
Patients will undergo ctDNA sampling at the 1-year timepoint using the commercially available Natera SignateraTM test.
at the 1-year timepoint
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.
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.
Time frame: 1 year
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.
Contact information is provided by the study sponsor or research team.
Memorial Sloan Kettering Cancer Center
Other
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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