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

Summary

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

Conditions

• Ovarian Neoplasms
• Ovarian Cancer
• Early Detection of Cancer

Interventions

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.

Sponsors & Collaborators

• Women's Hospital School Of Medicine Zhejiang University

  collaborator OTHER

• The Affiliated Hospital of Qingdao University

  collaborator OTHER

• Shanghai First Maternity and Infant Hospital

  collaborator OTHER

• The First Affiliated Hospital of Soochow University

  collaborator OTHER

• Xiangyang Central Hospital

  collaborator OTHER

• The First Hospital of Jilin University

  collaborator OTHER

• Renmin Hospital of Wuhan University

  collaborator OTHER

• General Hospital of Ningxia Medical University

  collaborator OTHER

• Wuhan Central Hospital

  collaborator OTHER

• The First Hospital of Lanzhou University, Gansu, China

  collaborator UNKNOWN

• Tongji Hospital affiliated to Tongji University

  collaborator UNKNOWN

• The Affiliated Tumor Hospital of Nantong University, Nantong, Jiangsu Province, China

  collaborator OTHER

• Tongji Hospital

  lead OTHER

Eligibility

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-07-01

Primary Completion

2029-06-30

Completion

2029-12-30

Countries

• China

Study Locations