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

NCT07670962 | Not Yet Recruiting

• 1 other identifier: 2026-0409
• Study Type: observational
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Ovarian Neoplasms; Carcinoma, Ovarian Epithelial; Ovarian Cancer

Keywords

ctDNA; Minimal Residual Disease; MRD; Liquid Biopsy

Outcome Measures

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.

  Up to 36 months (From the completion of first-line therapy until documented recurrence or the end of the study follow-up period)

Study Arms (1)

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

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.

Advanced Epithelial Ovarian Cancer Cohort

Eligibility Criteria

• Age: 19 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Asan Medical Center: lead

Biospecimen

Retention: SAMPLES WITH DNA

Blood Samples: Peripheral whole blood will be collected to separate plasma for cell-free DNA (cfDNA) extraction and subsequent NGS-based circulating tumor DNA (ctDNA) analysis. Additional blood components, including serum and peripheral blood mononuclear cells (PBMCs), will also be processed and cryopreserved. Tissue Samples: Archival tumor tissue samples (Formalin-Fixed Paraffin-Embedded \[FFPE\] blocks or slides) obtained from the initial diagnostic biopsy or primary/interval debulking surgery will be retained for baseline somatic mutation profiling via tissue NGS testing.

MeSH Terms

Conditions

Ovarian Neoplasms; Carcinoma, Ovarian Epithelial; Neoplasm, Residual

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Jeong-Yeol Park, MD, PhD

CONTACT

+82-2-3010-3646; catgut1-0@hanmail.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 22, 2026
• First Posted: June 26, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: June 26, 2026

Record last verified: 2026-06