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

June 22, 2026 updated by: Jeong-Yeol Park, MD, PhD, Asan Medical Center

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Despite high initial response rates to standard first-line therapies (surgery and platinum-based chemotherapy), the majority of patients with advanced high-grade epithelial ovarian cancer experience recurrence within three years. Traditional surveillance methods, including the CA-125 tumor marker and radiological imaging, often lack the sensitivity required to detect minimal residual disease (MRD) at a molecular level, limiting the window for early therapeutic intervention. Circulating tumor DNA (ctDNA) analysis has emerged as a promising, non-invasive technology capable of reflecting tumor-specific genetic mutations and real-time molecular profiling.

This prospective, non-interventional cohort study aims to comprehensively evaluate the clinical utility of blood-based ctDNA as an independent biomarker for predicting recurrence in patients with FIGO stage III-IV epithelial ovarian cancer. The primary objective is to determine whether the presence of ctDNA (MRD positivity) measured immediately after the completion of standard first-line therapy correlates significantly with Relapse-Free Survival (RFS).

To establish a baseline mutational profile, tumor tissue obtained during initial biopsy or debulking surgery (primary or interval) will undergo Next-Generation Sequencing (NGS). Longitudinally, peripheral blood samples (20 mL) will be collected at predefined critical time points: at initial diagnosis (prior to treatment), post-surgery, within 2-4 weeks after the completion of first-line adjuvant or maintenance therapy (baseline for post-treatment MRD), and every 3 months during the follow-up period for up to 36 months or until disease recurrence.

Cell-free DNA (cfDNA) will be extracted from the collected plasma and analyzed using a highly sensitive, validated NGS-based multigene panel (AlphaLiquid® 100). The analysis will quantify major genetic variants (Variant Allele Frequency [VAF] ≥ 0.1%).

By tracking changes in ctDNA dynamics and comparing them with standard follow-up modalities, the study will investigate the lead time of ctDNA detection over radiological recurrence and compare its sensitivity and specificity against CA-125. Ultimately, this research seeks to provide robust scientific evidence to support the integration of ctDNA-based MRD monitoring into standard surveillance protocols, potentially enabling personalized tracking strategies and earlier clinical decision-making for high-risk ovarian cancer patients.

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study 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.

Description

Inclusion Criteria:

Women aged 19 years or older. Pathologically confirmed high-grade serous, endometrioid, clear cell, or mixed type ovarian cancer.

FIGO stage III or IV. Patients who have completed primary debulking surgery (PDS) or interval debulking surgery (IDS) and platinum-based chemotherapy (subsequent maintenance therapy, such as bevacizumab or PARP inhibitors, is allowed).

Patients showing radiological or clinical Complete Response (CR) after the completion of platinum-based chemotherapy.

Written informed consent for the study.

Exclusion Criteria:

Radiological progressive disease during or immediately after treatment. Expected survival of 3 months or less. Immunodeficiency or pathological bleeding tendencies. Unable to undergo blood tests or unwilling to undergo repeated blood sampling. Concurrent other solid tumors or history of malignant tumors within the last 5 years.

Refusal to consent to participate in this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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.
Up to 36 months (From the completion of first-line therapy until documented recurrence or the end of the study follow-up period)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asan Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

June 30, 2028

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

June 22, 2026

First Submitted That Met QC Criteria

June 22, 2026

First Posted (Actual)

June 26, 2026

Study Record Updates

Last Update Posted (Actual)

June 26, 2026

Last Update Submitted That Met QC Criteria

June 22, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2026-0409

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Individual participant data (IPD) will not be shared with other researchers to strictly protect patient privacy and confidentiality. According to the study protocol and institutional regulations, access to all research data is strictly limited to the principal investigator and the minimum number of authorized research personnel approved by the Institutional Review Board (IRB). All collected data is coded to prevent external exposure of any personally identifiable information. Furthermore, in compliance with South Korea's Bioethics and Safety Act and Personal Information Protection Act, all study-related records will be securely retained for 3 years after the completion of the study and subsequently permanently destroyed, which precludes external data sharing.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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