Blood-Based Minimal Residual Disease in Advanced Epithelial Ovarian Cancer After 1st Line Therapy
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age19+
SponsorAsan Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial population
The study population consists of adult women (aged 19 years or older) diagnosed with FIGO stage III or IV advanced epithelial ovarian cancer, specifically including high-grade serous, endometrioid, clear cell, or mixed carcinomas. To be eligible, patients must have successfully completed their standard first-line therapy, consisting of primary debulking surgery (PDS) or interval debulking surgery (IDS) paired with platinum-based chemotherapy, and must have achieved a clinical or radiological complete response (CR) at the end of treatment. A total of 200 patients meeting these criteria will be enrolled in this prospective cohort.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Blood-based ctDNA minimal residual disease (MRD) test
Diagnostic testA 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.
Treatment groups
300 Participants
are divided into 1 treatment groupGroup A: Advanced Epithelial Ovarian Cancer Cohort1 intervention
Trial outcomes
Primary outcomes
1
Relapse-Free Survival (RFS) according to ctDNA Minimal Residual Disease (MRD) status
Relapse-Free Survival (RFS) is defined as the time from the completion of standard first-line therapy to the date of the first documented radiological or clinical disease recurrence, or death from any cause. This measure evaluates the correlation between ctDNA positivity (baseline MRD status, measured within 2-4 weeks after completing 1st-line therapy) and RFS. The median RFS and Hazard Ratio (HR) will be compared between the ctDNA-positive and ctDNA-negative patient groups.
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)Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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