Using ctDNA to Monitor Recurrence in High-risk Endometrial Cancer
Exploring the Potential of ctDNA-MRD for Recurrence Surveillance and Prognostic Evaluation in High-risk Endometrial Cancer
This study is testing whether a blood test that looks for tumor DNA can help people with high-risk endometrial cancer catch any return of their cancer earlier after surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | Female |
| Sponsor | The First Hospital of Jilin University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Chang Chun, Jilin) |
| Trial ID | NCT06341855 on ClinicalTrials.gov |
What this trial studies
This study investigates the use of circulating tumor DNA (ctDNA) to monitor minimal residual disease (MRD) in patients with high-risk endometrial cancer after surgical treatment. It aims to evaluate the prognostic value of ctDNA-MRD for detecting early recurrence and metastasis, which traditional imaging methods may miss. By analyzing mutation sites in tumor tissue, the study seeks to provide a personalized monitoring strategy for patients, potentially leading to timely interventions. The research will involve collecting blood samples and clinical data to assess the effectiveness of ctDNA-MRD as a biomarker.
Who should consider this trial
Good fit: Ideal candidates include patients with high-risk endometrial carcinoma who have undergone radical surgery and show no evidence of disease post-operation.
Not a fit: Patients with endometrial stromal sarcoma or those who have contraindications to radiotherapy and chemotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to earlier detection of cancer recurrence, allowing for timely and potentially life-saving interventions.
How similar studies have performed: Other studies have shown promise in using ctDNA as a biomarker for various cancers, suggesting potential success for this novel approach in endometrial cancer.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * (1) endometrial carcinoma with high risk of recurrence after radical surgery: stage I G3 endometrioid carcinoma, serous carcinoma, clear cell carcinoma, carcinosarcoma, dedifferentiated / undifferentiated carcinoma, II-IV stage endometrial carcinoma, operable recurrent endometrial carcinoma. (2) the physical status (PS) score of the eastern tumor tissue cooperation group (ECOG) was 0 or 1. (3) the treatment process should cooperate with the provision of clinicopathological and imaging data needed for the research process. (4) cooperate with the follow-up and collect the blood of the clinical curative effect evaluation node, and agree to use the test data for follow-up research and product development. (5) after operation, imaging examination showed no evidence of local disease or distant metastasis. Exclusion Criteria: * (1) histological diagnosis of endometrial stromal sarcoma. (2) there are contraindications of radiotherapy and chemotherapy. (3) any other patients who may have poor compliance with the procedures and requirements of the study have been judged by the researchers. (4) designated evaluation methods such as imaging can not be accepted or provided.
Where this trial is running
Chang Chun, Jilin
- the 1st hospital of Jilin University — Chang Chun, Jilin, China (Recruiting)
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.