ctDNA Testing for Endometrial Cancer
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.12345Why 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.12467
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
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive standard chemotherapy and immune checkpoint inhibitor (ICI) treatment
Evaluation
Participants undergo ctDNA testing to inform treatment decisions
Maintenance/Decision
Based on ctDNA results, participants and doctors decide on continuation or cessation of ICI treatment
Follow-up
Participants are monitored for health outcomes and cancer status
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?
2
Treatment groups
Experimental Treatment
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Memorial Sloan Kettering Cancer Center
Lead Sponsor
Citations
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.
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 ...
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.
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/fulltextPost-surgical ctDNA-based molecular residual disease ...
Post-surgical ctDNA detection is prognostic of poor recurrence-free survival in patients with stage I endometrial cancer.
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 ...
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 ...
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