Can a simple blood test spot ovarian cancer before it starts?
NCT ID NCT07764744
First seen Aug 14, 2026 · Last updated Sep 11, 2026 · Updated 1 time
Summary
This study is looking at whether a blood test called Galleri can help detect ovarian cancer early in people with BRCA1 or BRCA2 gene changes, who are at higher risk. Participants will give a blood sample and answer questionnaires about their experience. The study will also check how well the test finds ovarian cancer or precancerous conditions compared to standard care.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Galleri multi-cancer early detection (MCED) blood test
- What this could lead to
- If successful, this could lead to a simple blood test that helps catch ovarian cancer earlier in high-risk individuals, potentially improving outcomes.
- What could go wrong
- This is an early feasibility study with a small number of participants. The test may not be accurate enough for routine use, and results may not apply to the broader population.
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.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 70 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Jul 2039
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.
- Ages
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35 years and older
- 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: Cohort A participants must meet all of the following criteria: 1. Age ≥ 35 years (based on current National Comprehensive Cancer Network guidelines35 for risk-reducing gynecologic surgery) with no upper age limit 2. Confirmed germline PV or likely PV in the BRCA1 or BRCA2 genes, documented by CLIA-certified genetic testing. 3. Scheduled to undergo risk-reducing gynecologic surgery (salpingo-oophorectomy or salpingectomy with or without hysterectomy) at the study site. 4. Willing and able to provide informed consent in English This initial phase is limited to English-speaking participants. This limitation is due to feasibility considerations for initial qualitative instrument validation; future phases will incorporate translated materials Cohort B participants must meet all of the following criteria: 5. Age ≥ 35 years with no upper age limit. 6. STIC lesion previously identified on surgical pathology within the prior 10 years. 7. Willing and able to undergo baseline and annual research blood draws for up to 10 years following STIC lesion diagnosis. 8. Willing and able to provide informed consent in English Exclusion Criteria: Cohort A: 1. Pregnant or breastfeeding at the time of enrollment. 2. Prior removal of bilateral fallopian tubes and/or bilateral ovaries. 3. Active diagnosis of cancer. 4. Prior or active diagnosis of epithelial ovarian, fallopian tube, or primary peritoneal cancer at the time of consent. 5. Patients with a history of cancer are eligible when \> 2 years no evidence of disease. 6. Inability to provide informed consent. 7. Concurrent participation in another interventional trial that may confound study outcomes. Cohort B: 1. Pregnant or breastfeeding at the time of enrollment. 2. Active diagnosis of cancer. 3. Prior or active diagnosis of epithelial ovarian, fallopian tube, or primary peritoneal cancer at the time of consent (prior STIC lesion is NOT a contraindication to enrollment). 4. Patients with a history of cancer are eligible when \> 2 years no evidence of disease. 5. Inability to provide informed consent. 6. Concurrent participation in another interventional trial that may confound study outcomes.
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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
2 sites. 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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MD Anderson Cancer Center
Houston, Texas, 77030, United States
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Weill Cornell Medicine
New York, New York, 10065, United States
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Other studies related to the condition(s) this trial covers.
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- Can an oral drug that starves tumors help Hard-to-Treat cancers?
- Can engineered immune cells outsmart Drug-Resistant ovarian cancer?
- Can a targeted drug keep ovarian cancer at bay longer?