ctDNA Testing for Endometrial Cancer

Recruiting at 6 trial locations

Overseen By Ying Liu, MD, MPH

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Memorial Sloan Kettering Cancer Center

Must be taking: Chemotherapy, Immune checkpoint inhibitors

Must not be taking: Anti-PD-1, Anti-PD-L1

Disqualifiers: Pregnancy, Nursing, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 1 year

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how a blood test called ctDNA testing can guide treatment plans for individuals with advanced endometrial cancer. The focus is on patients whose cancer exhibits specific gene changes. The test determines if cancer DNA remains in the blood after a year of standard treatments. Based on test results, patients will either continue or stop their ongoing treatment. Eligible participants have been diagnosed with advanced endometrial cancer, possess specific gene changes (MMR-D or MSI-H), and have completed standard chemotherapy and immune treatments without new disease progression. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could personalize future treatment plans.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It might be best to discuss this with the trial coordinators or your doctor.

What prior data suggests that ctDNA testing is safe for endometrial cancer patients?

Research has shown that ctDNA testing is generally safe. In past studies, this test examined cancer DNA in the blood of patients with endometrial cancer, helping predict patient outcomes and the likelihood of cancer recurrence. Importantly, ctDNA testing doesn't involve medication or invasive procedures, making it easy to handle and low risk.

In these studies, patients who were ctDNA-negative, meaning no cancer DNA was found, had a very low chance of cancer returning, with only 6% experiencing recurrence. This suggests the test provides valuable information without adding health risks. There are no reports of negative effects from the ctDNA test itself, as it only requires a blood test. The primary purpose of ctDNA testing is to guide treatment decisions, not to serve as a treatment.

Overall, ctDNA testing is considered safe and aids doctors and patients in making informed choices about ongoing cancer care. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about ctDNA testing for endometrial cancer because it offers a personalized approach to monitoring treatment effectiveness. Unlike standard treatments that follow a one-size-fits-all protocol, ctDNA testing allows for real-time tracking of cancer DNA in the blood. This means doctors can tailor treatment plans based on whether cancer DNA is detected, potentially sparing some patients from unnecessary treatments. By using ctDNA as a guide, there is hope for more targeted and efficient management of endometrial cancer, leading to better outcomes and fewer side effects.

What evidence suggests that ctDNA testing is effective for making treatment decisions in endometrial cancer?

Studies have shown that testing for ctDNA can help predict outcomes for patients with endometrial cancer. In this trial, participants will be divided into two groups based on their ctDNA test results. If ctDNA is found in a patient, there is often a higher chance that the cancer might return. Thus, ctDNA testing serves as a useful tool to understand a patient's likely health outcome. Research has also found that ctDNA testing can accurately identify genetic changes in the cancer, aiding doctors in making better treatment decisions. Overall, ctDNA testing shows promise in guiding treatment for advanced endometrial cancer. ^{1 2 4 6 7}

Who Is on the Research Team?

Ying Liu, MD, MPH

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

This trial is for individuals with advanced or recurrent endometrial cancer that has specific genetic changes known as MMR-D or MSI-H. Participants will have already undergone a year of standard chemotherapy and immune checkpoint inhibitor treatment.

Inclusion Criteria

My cancer is at stage IV.

I am eligible for or have had initial surgery.

My cancer is MMR deficient or has high microsatellite instability.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive standard chemotherapy and immune checkpoint inhibitor (ICI) treatment

1 year

Evaluation

Participants undergo ctDNA testing to inform treatment decisions

1 visit

Maintenance/Decision

Based on ctDNA results, participants and doctors decide on continuation or cessation of ICI treatment

Ongoing

Follow-up

Participants are monitored for health outcomes and cancer status

6 months

What Are the Treatments Tested in This Trial?

Interventions

• ctDNA Testing

Trial Overview The study evaluates the use of ctDNA testing to guide treatment decisions after initial therapy. It aims to determine if this testing can help decide whether to continue maintenance immune checkpoint inhibitor treatments beyond one year.

How Is the Trial Designed?

Group I: ctDNA-positive group Experimental Treatment 2 Interventions

Participants 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.

Group II: ctDNA-negative group Experimental Treatment 2 Interventions

Participants 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.

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11647206/

Genomic Landscape of ctDNA and Real-World Outcomes ... This study showed that ctDNA analysis has the potential to accurately detect the genomic landscape and predict patient outcomes in endometrial cancer.

2. dailynews.ascopubs.org dailynews.ascopubs.org/do/role-ctdna-ovarian-and-endometrial-cancers

What Is the Role of ctDNA in Ovarian and Endometrial ... In a recent meta-analysis, patients with ovarian cancer with detectable or high ctDNA had poorer progression-free and overall survival. ... High ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S009082582500071X

Prognostic value of assessing ctDNA in patients with ... Our results demonstrated the feasibility of using an off-the-shelf gene panel to detect ctDNA in patients with endometrial cancer.

4. targetedonc.com targetedonc.com/view/ctdna-endometrial-cancer-recurrence-risk

ctDNA Detects Endometrial Cancer Recurrence Risk ... The study demonstrates the potential ctDNA holds for prognosis and risk stratification in patients with early-stage endometrial cancer.

5. gynecologiconcology-online.net gynecologiconcology-online.net/article/S0090-8258(23)01631-1/fulltext

Post-surgical ctDNA-based molecular residual disease ... Post-surgical ctDNA detection is prognostic of poor recurrence-free survival in patients with stage I endometrial cancer.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07270666

A Study Using ctDNA Testing to Inform Standard-of-Care ... The researchers will see how doctors and their patients use the results of ctDNA testing after 1 year of standard chemotherapy and immune ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12487656/

Using Circulating Tumor DNA–Based Molecular Residual ... ctDNA positivity was associated with significantly reduced RFS postoperatively (hazard ratio [HR], 7.6; P = .003) and postdefinitive therapy (HR ...