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Prospective Cohort Study of Minimal Residual Disease(MRD) Testing for Early Recurrence Detection in Endometrial and Cervical Cancer

NCT07382505 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 600

Last updated 2026-02-02

No results posted yet for this study

Summary

This study aims to evaluate the clinical performance of blood-based Minimal Residual Disease (MRD) testing using circulating tumor DNA (ctDNA) in patients with endometrial and cervical cancer. The researchers will investigate whether MRD detection can identify cancer recurrence earlier than current standard imaging or clinical methods (providing a "lead time"). Participants will undergo blood collection at specific time points, including at diagnosis, after surgery, and during regular follow-up visits. The study will also assess the correlation between MRD status and survival outcomes, such as Relapse-Free Survival (RFS) and Overall Survival (OS). The goal is to establish a foundation for personalized treatment strategies based on molecular monitoring.

Conditions

Interventions

GENETIC

Serial blood collection for MRD testing

Participants will undergo serial peripheral blood collection (approximately 20 mL per visit) at predefined clinical milestones: baseline (diagnosis), post-operative (2-4 weeks after surgery), post-adjuvant therapy (2-4 weeks after completion of chemotherapy or CCRT), and during follow-up surveillance (every 3 months for up to 24 months). The collected blood will be used to perform Minimal Residual Disease (MRD) testing by analyzing circulating tumor DNA (ctDNA). Archival tumor tissue (FFPE blocks or slides) from initial diagnosis or surgery will also be collected to identify patient-specific somatic mutations for the MRD assay. This study is observational and does not involve any changes to the patient's standard of care or medical treatment.

Sponsors & Collaborators

  • Asan Medical Center

    lead OTHER

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-15
Primary Completion
2027-06-30
Completion
2027-12-31

Countries

  • South Korea

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07382505 on ClinicalTrials.gov