Identifying early recurrence risk in endometrial cancer patients using circulating tumor DNA
Prospective Validation of the Association Between Circulating Tumor DNA Detection and Risk of Metastatic Relapse in Patients With Localized Endometrial Cancer
This study is trying to see if checking for certain DNA in the blood can help find out which endometrial cancer patients are at high risk of their cancer coming back after surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 130 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Paris) |
| Trial ID | NCT05955079 on ClinicalTrials.gov |
What this trial studies
This observational study aims to identify patients at high risk of early recurrence after surgery for endometrial cancer by detecting circulating tumor DNA (ctDNA). Utilizing advanced digital PCR methods, the study focuses on analyzing ctDNA to better predict prognosis in patients with localized endometrial cancer. The research involves a prospective biological cohort established at Hôpital Cochin, where pre- and post-operative ctDNA levels will be evaluated to assess their prognostic impact. The study leverages a validated methylation signature to enhance the sensitivity and specificity of ctDNA detection.
Who should consider this trial
Good fit: Ideal candidates include female patients over 18 years old with histologically confirmed endometrial cancer who are eligible for surgical intervention.
Not a fit: Patients who are not eligible for upfront curative surgical treatment or who refuse to consent to the study will not benefit.
Why it matters
Potential benefit: If successful, this study could lead to improved risk stratification and personalized treatment strategies for patients with endometrial cancer.
How similar studies have performed: Other studies utilizing ctDNA detection in various cancers have shown promising results, indicating potential success for this approach in endometrial cancer.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Female patients over 18 years of age who are potentially eligible for inclusion in the OncoCentre collection (registered as a patient at APHP, without legal protection measures, affiliated with a social security system) * Patients diagnosed with histologically documented endometrial cancer on an endometrial biopsy * Surgical intervention performed at Hopital Cochin Exclusion Criteria: * Failure to sign the OncoCentre consent form * Refusal of OncoCentre consent * Patient not eligible for upfront curative surgical treatment
Where this trial is running
Paris
- Hôpital Cochin — Paris, France (Recruiting)
Study contacts
- Study coordinator: Guillaume BEINSE, MD, PhD
- Email: guillaume.beinse@aphp.fr
- Phone: +33 1 58 41 14 54
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.