Blood-Based Minimal Residual Disease in Advanced Epithelial Ovarian Cancer After 1st Line Therapy

Sponsor
Asan Medical Center
Study ID
NCT07670962
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

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

Interventions

  • Blood-based ctDNA minimal residual disease (MRD) test — DIAGNOSTIC_TEST
    A non-invasive diagnostic blood test designed to monitor minimal residual disease (MRD). The procedure involves extracting cell-free DNA (cfDNA) from peripheral blood plasma and performing Next-Generation Sequencing (NGS) using a validated multigene assay (AlphaLiquid 100). This test detects and quantifies tumor-specific genetic mutations (Variant Allele Frequency \[VAF\] ≥ 0.1%) to evaluate molecular-level recurrence after the completion of standard first-line therapy.

Study Details

The purpose of this observational study is to learn if a specialized blood test can help predict whether advanced ovarian cancer will return after a patient's initial treatments are finished. Researchers are inviting women who have been diagnosed with stage III or IV epithelial ovarian cancer and have recently completed their first-line treatments, which include surgery and platinum-based chemotherapy. The study focuses on "circulating tumor DNA" (ctDNA), which are tiny fragments of genetic material that cancer cells release into the bloodstream as they break down. Finding these DNA fragments in the blood when a patient appears to be cancer-free on standard tests is known as assessing for minimal residual disease (MRD). Because this is an observational study, participants will receive standard medical care as directed by their doctor. For the research portion, participants will provide blood samples at specific times: at the time of diagnosis, shortly after surgery, right after finishing their first-line chemotherapy, and then every 3 months during regular follow-up visits. Researchers will also analyze a sample of the tumor tissue that was already removed during the patient's standard surgery. By tracking these participants for up to 3 years, researchers hope to discover if the ctDNA test can accurately identify patients who have a high risk of their cancer returning, and if it can detect this earlier than traditional imaging scans or standard blood tests like CA-125.

Key Dates

First listed
Jun 26, 2026
Start date
Jul 1, 2026
Status verified
Jun 2026
Primary completion
Jun 30, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
300 participants (estimated)

Arms

  • Arm: Advanced Epithelial Ovarian Cancer Cohort
    Patients with FIGO stage III-IV high-grade serous, endometrioid, clear cell, or mixed type ovarian cancer who have completed primary or interval debulking surgery and platinum-based chemotherapy, and show a complete response. This cohort will undergo non-invasive blood-based minimal residual disease (MRD) monitoring using an NGS-based ctDNA assay (AlphaLiquid®100) to evaluate its utility in predicting recurrence.

Primary Outcome Measure

Relapse-Free Survival (RFS) according to ctDNA Minimal Residual Disease (MRD) status [ Time Frame: Up to 36 months (From the completion of first-line therapy until documented recurrence or the end of the study follow-up period) ]

Central Contacts

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