Using blood tests to predict cancer recurrence in endometrial cancer patients
A Pilot Investigation to Determine the Utility of Liquid Biopsies and Tumor Molecular Profiling in Predicting Recurrence in Endometrial Cancer
This study is testing if blood tests can help predict if endometrial cancer will come back by looking for cancer cells and genetic changes in patients during their treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | M.D. Anderson Cancer Center Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT05049538 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the effectiveness of liquid biopsies as a non-invasive method for detecting cancer cells in patients with various subtypes of endometrial cancer. It involves collecting blood and tissue samples from participants at different stages of treatment, including before and after surgery and during chemotherapy. The study will analyze genetic mutations in circulating cell-free DNA (ccfDNA) and compare these findings to traditional tumor sequencing. Additionally, it will explore the immune profile of the cancer and assess the presence of malignant cells in the vagina before and after surgery.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 and older with a histologic diagnosis of endometrial cancer who are candidates for primary surgical treatment.
Not a fit: Patients who have previously received chemotherapy or radiation therapy for endometrial cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a less invasive method for monitoring cancer recurrence, potentially improving patient outcomes.
How similar studies have performed: Other studies have shown promise in using liquid biopsies for cancer detection, suggesting this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Women age 18 years and older * Histologic diagnosis of endometrial cancer * Candidate for primary surgical treatment or has recently had prior primary surgery * Willing and able to provide informed consent Exclusion Criteria: Patients who have received prior treatment including chemotherapy or radiation therapy for endometrial cancer. Prior hormonal therapy for the treatment of endometrial cancer is allowed. Patients with prior primary surgery will be allowed to enroll in this trial if the patient has not received any chemotherapy or radiation at the time of enrollment. Note: patients with a history of other cancers may be enrolled after discussion with the PI if it is determined that they are at low risk for recurrence or metastasis.
Where this trial is running
Houston, Texas
- M D Anderson Cancer Center — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Pamela T Soliman — M.D. Anderson Cancer Center
- Study coordinator: Pamela T Soliman, MD
- Email: psoliman@mdanderson.org
- Phone: 713-745-2352
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.