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

Sponsor
Tongji Hospital
Study ID
NCT07593833
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

Eligibility Criteria

Sex
FEMALE
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Blood-Based cfDNA Methylation Assay for Ovarian Cancer Detection — DIAGNOSTIC_TEST
    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.

Study Details

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

Key Dates

First listed
May 18, 2026
Start date
Jul 1, 2026
Status verified
Apr 2026
Primary completion
Jun 30, 2029
Completion
Dec 30, 2029

Study Design

Enrollment
1,000 participants (estimated)

Arms

  • Arm: 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.
  • Arm: 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.

Primary Outcome Measure

Diagnostic sensitivity [ Time Frame: From blood sample collection to final clinical and/or pathological diagnosis, up to 6 months ]

Central Contacts

Find similar trials

Nationwide
Ovarian cancer trialsOncology trialsGynecologic oncology trialsWomen's health trials

Related Studies