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NCT07670962

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

Sponsor: Asan Medical Center

View on ClinicalTrials.gov

Summary

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.

Official title: The Role of Blood-Based Minimal Residual Disease in Patients With Advanced Epithelial Ovarian Cancer After 1st Line Therapy

Key Details

Gender

FEMALE

Age Range

19 Years - Any

Study Type

OBSERVATIONAL

Enrollment

300

Start Date

2026-07-01

Completion Date

2028-12-31

Last Updated

2026-06-26

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

Blood-based ctDNA minimal residual disease (MRD) 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.