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

Sponsor
Asan Medical Center
Study ID
NCT07382505
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
FEMALE
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Serial blood collection for MRD testing — GENETIC
    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.

Study Details

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.

Key Dates

First listed
Feb 2, 2026
Start date
Feb 15, 2026
Status verified
Jan 2026
Primary completion
Jun 30, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
600 participants (estimated)

Arms

  • Arm: endometrial cancer cohort
    patients diagnosed with endometrial cancer
  • Arm: cervical cancer cohort
    patients diagnosed with cervical cancer

Primary Outcome Measure

Progression-Free Survival (PFS) [ Time Frame: From the date of enrollment until the date of first documented recurrence or death from any cause, whichever occurs first, assessed up to 48 months. ]

Central Contacts

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