New blood test aims to catch ovarian cancer sooner
NCT ID NCT07593833
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study will test a new blood test that looks for DNA changes to detect ovarian cancer, especially in early stages. Researchers will compare test results from 1,000 women with and without ovarian cancer to see how accurate it is. If it works well, it could lead to a simple screening tool for earlier diagnosis.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Blood-based cfDNA methylation test
- What this could lead to
- If successful, this blood test could help detect ovarian cancer earlier, potentially improving treatment outcomes and survival rates.
- What could go wrong
- This is an early validation study, not yet recruiting. The test may not be accurate enough for widespread use, and results need confirmation in larger, diverse populations.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 1,000 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jul 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
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.
- Ages
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Children (under 18), adults (18 to 64) and older adults (65 and over)
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, 430030, China
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