Blood-Based Minimal Residual Disease in Advanced Epithelial Ovarian Cancer After 1st Line Therapy
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.
연구 개요
상태
상세 설명
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.
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Jeong-Yeol Park, MD, PhD
- 전화번호: +82-2-3010-3646
- 이메일: catgut1-0@hanmail.net
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
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.
|
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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Relapse-Free Survival (RFS) according to ctDNA Minimal Residual Disease (MRD) status
기간: 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)
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 2026-0409
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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