Prospective Sample Collection Study for a Blood-Based cfDNA Methylation Assay for Ovarian Cancer Detection

May 12, 2026 updated by: Qinglei Gao, Tongji Hospital

Prospective Clinical Validation Study of a Blood-Based cfDNA Methylation Assay for the Detection of Ovarian Cancer

The goal of this observational study is to learn whether a blood-based cell-free DNA (cfDNA) methylation assay can help detect ovarian cancer, especially early-stage ovarian cancer, in women undergoing clinical evaluation for ovarian tumors or gynecologic diseases. The main questions it aims to answer are:

How well can this assay distinguish ovarian cancer from benign gynecologic diseases? How accurately can this assay detect early-stage ovarian cancer and other ovarian tumor subtypes?

Researchers will compare the test results from participants with ovarian cancer and participants with benign gynecologic diseases to evaluate the diagnostic performance of the assay.

Participants will:

Provide blood samples for cfDNA methylation testing Allow researchers to collect clinical and pathological information related to their diagnosis Be grouped according to their final clinical or pathological diagnosis for analysis

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

1000

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

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430030
        • Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology
        • 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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Women with complex ovarian or adnexal masses, including suspected ovarian-origin pelvic masses, who are planned to undergo first-time surgery or biopsy/pathologic sampling related to the current lesion at participating centers and are expected to have a postoperative pathologic diagnosis available as the reference standard. The main analysis population consists of participants with pathologically confirmed early-stage invasive ovarian malignancies (FIGO 2014 stage IA-IIB) and participants with pathologically confirmed benign ovarian or adnexal diseases. Participants with borderline ovarian tumors, advanced-stage invasive malignancies, and, where available, high-risk or precursor lesions may also be enrolled as exploratory cohorts.

Description

Inclusion Criteria:

  • Female participants.
  • Participants with an ovarian/adnexal mass who are planned to undergo, for the first time at the current center, surgery or biopsy/pathologic sampling related to the current lesion, with an expected pathologic diagnosis available as the reference standard.
  • Imaging evaluation during screening suggests a unilateral or bilateral, unilocular or multilocular cystic-solid or solid ovarian/adnexal mass requiring differential diagnosis.
  • An adequate peripheral blood sample can be collected before the first surgery or before initiation of any systemic anti-tumor treatment for the current ovarian/adnexal mass, and the sample can be processed and stored within the required time according to the unified study procedures.
  • Clinical data and postoperative pathologic results are expected to be sufficiently complete to provide key information for subsequent analyses.
  • The participant or her legally authorized representative voluntarily signs written informed consent after being fully informed.

Exclusion Criteria:

  • The participant has already received systemic anti-tumor treatment for the current ovarian/adnexal lesion under evaluation, such as chemotherapy, targeted therapy, immunotherapy, or radiotherapy, or has already undergone definitive tumor resection or comprehensive staging surgery, and is undergoing surgery only for residual or recurrent lesions.
  • No pathologic diagnosis is ultimately obtained for the current ovarian/adnexal mass, or no analyzable pathologic conclusion can be established.
  • Imaging findings at screening are highly typical of benign mature cystic teratoma.
  • Ovarian cancer combined with another malignant tumor.
  • There are obvious noncompliances during sample collection, transport, or processing, resulting in severe hemolysis, contamination, or seriously insufficient sample volume, such that the sample cannot meet quality control requirements for cfDNA methylation testing or subsequent analyses.
  • Any other condition that, in the investigator's judgment, makes the participant unsuitable for enrollment.

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
Ovarian Cancer
Women with ovarian cancer who provide blood samples for cfDNA methylation testing. Participants will be classified into this cohort based on their final clinical and/or pathological diagnosis. This cohort will be used to evaluate the sensitivity of the assay, including its performance in different histologic subtypes and early-stage disease.
Diagnostic test: Blood-Based cfDNA Methylation Assay for Ovarian Cancer Detection
A blood-based diagnostic test performed on plasma samples to analyze a proprietary cfDNA methylation panel for ovarian cancer detection. The assay uses a PCR-based detection method, and test results will be compared with final clinical and/or pathological diagnoses to evaluate diagnostic performance.
Other Names:
  • Plasma cfDNA Methylation Test
Benign Gynecologic Diseases
Women with benign gynecologic diseases who provide blood samples for cfDNA methylation testing. Participants will be classified into this cohort based on their final clinical and/or pathological diagnosis. This cohort will be used to evaluate the specificity of the assay.
Diagnostic test: Blood-Based cfDNA Methylation Assay for Ovarian Cancer Detection
A blood-based diagnostic test performed on plasma samples to analyze a proprietary cfDNA methylation panel for ovarian cancer detection. The assay uses a PCR-based detection method, and test results will be compared with final clinical and/or pathological diagnoses to evaluate diagnostic performance.
Other Names:
  • Plasma cfDNA Methylation Test

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic sensitivity
Time Frame: From blood sample collection to final clinical and/or pathological diagnosis, up to 6 months
Diagnostic sensitivity of the blood-based cfDNA methylation panel, defined as the proportion of participants with ovarian cancer who test positive, using final clinical and/or pathological diagnosis as the reference standard.
From blood sample collection to final clinical and/or pathological diagnosis, up to 6 months
Diagnostic specificity
Time Frame: From blood sample collection to final clinical and/or pathological diagnosis, up to 6 months
Diagnostic specificity of the blood-based cfDNA methylation panel, defined as the proportion of participants without ovarian cancer who test negative, using final clinical and/or pathological diagnosis as the reference standard.
From blood sample collection to final clinical and/or pathological diagnosis, up to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic performance of the blood-based cfDNA methylation panel combined with CA125 for early-stage ovarian cancer detection
Time Frame: From blood sample collection to final clinical and/or pathological diagnosis, up to 6 months
Diagnostic performance of the blood-based cfDNA methylation panel combined with CA125 for detecting early-stage ovarian cancer, using final clinical and/or pathological diagnosis as the reference standard.
From blood sample collection to final clinical and/or pathological diagnosis, up to 6 months
Diagnostic performance of the blood-based cfDNA methylation panel combined with ROMA score for early-stage ovarian cancer detection
Time Frame: From blood sample collection to final clinical and/or pathological diagnosis, up to 6 months
Diagnostic performance of the blood-based cfDNA methylation panel combined with ROMA score for detecting early-stage ovarian cancer, using final clinical and/or pathological diagnosis as the reference standard.
From blood sample collection to final clinical and/or pathological diagnosis, up to 6 months
Detection performance of the blood-based cfDNA methylation panel in borderline ovarian tumors
Time Frame: From blood sample collection to final clinical and/or pathological diagnosis, up to 6 months
Detection performance of the blood-based cfDNA methylation panel in participants with borderline ovarian tumors, using final clinical and/or pathological diagnosis as the reference standard.
From blood sample collection to final clinical and/or pathological diagnosis, up to 6 months
Detection performance of the blood-based cfDNA methylation panel in precursor lesions or high-risk populations
Time Frame: From blood sample collection to final clinical and/or pathological diagnosis or clinical classification, up to 6 months
Detection performance of the blood-based cfDNA methylation panel in participants with precursor lesions or in populations at high risk for ovarian cancer, using final clinical and/or pathological diagnosis or clinical classification as the reference standard.
From blood sample collection to final clinical and/or pathological diagnosis or clinical classification, up to 6 months
Diagnostic performance of the blood-based cfDNA methylation panel across histologic subtypes of ovarian cancer
Time Frame: From blood sample collection to final clinical and/or pathological diagnosis, up to 6 months
Diagnostic performance of the blood-based cfDNA methylation panel across histologic subtypes of ovarian cancer, using final clinical and/or pathological diagnosis as the reference standard.
From blood sample collection to final clinical and/or pathological diagnosis, up to 6 months

Collaborators and Investigators

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

Sponsor

Tongji Hospital

Collaborators

The Affiliated Hospital of Qingdao University
The First Affiliated Hospital of Soochow University
The First Hospital of Jilin University
Women's Hospital School Of Medicine Zhejiang University
Renmin Hospital of Wuhan University
General Hospital of Ningxia Medical University
Shanghai First Maternity and Infant Hospital
Wuhan Central Hospital
The Affiliated Tumor Hospital of Nantong University, Nantong, Jiangsu Province, China
Xiangyang Central Hospital
The First Hospital of Lanzhou University, Gansu, China
Tongji Hospital affiliated to Tongji University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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, 2029

Study Completion (Estimated)

December 30, 2029

Study Registration Dates

First Submitted

May 12, 2026

First Submitted That Met QC Criteria

May 12, 2026

First Posted (Actual)

May 18, 2026

Study Record Updates

Last Update Posted (Actual)

May 18, 2026

Last Update Submitted That Met QC Criteria

May 12, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TJ-OVMethy

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No individual participant data are planned to be shared at this time.

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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