An interventional study of Galleri Multi-Cancer Early Detection (MCED) Blood Test in Ovarian Neoplasms, BRCA 1 Gene Mutation and BRCA 2 Gene Mutation, sponsored by Weill Medical College of Cornell University. Not yet recruiting at 2 sites in United States. Open to female participants aged 35 Years and older. Per ClinicalTrials.gov, last updated 2026-10-16.
Sponsored by Weill Medical College of Cornell University · Not applicable, Interventional, and Diagnostic
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Among 1,778 studies in Ovarian Neoplasms with a site in United States — 280 open to participants now, 455 under way, 46 of them phase 3. Ovarian Neoplasms · United States.
Among the 1,778 studies in Ovarian Neoplasms with a site in United States, this one is the 573rd largest by planned enrollment of the 1,497 interventional ones that give a count, is one of 64 that started in 2026, is one of 202 with no phase, reaches primary completion later than 447 of the 453 other live ones, and was the 1,763rd registered.
3,385 studies on the registry are indexed under Ovarian Neoplasms; 792 are open to participants now.
Browse Ovarian Neoplasms studies →280 of the 1,778 studies in Ovarian Neoplasms with a site in United States are open now. Recruiting first, the newest first:
Michael J. Goodheart · Sites in United States
Ages 18–99 · Women only
Crescent Biopharma, Inc. · Sites in United States
Ages 18+
Merck Sharp & Dohme LLC · Sites in United States, Israel, Taiwan
Ages 18+ · Women only
University of Alabama at Birmingham · Sites in United States
Ages 18+
GE Healthcare · Sites in United States, Sweden
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 605 Ovarian Neoplasms studies recruiting now, 442 (73%) set no upper age limit and 107 (18%) stop at 75 or younger; 39 take children under 18; 45 take healthy volunteers.
This study: 35 Years and older · female · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
1,778 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 768 · Phase 2 718 · Phase 3 114 · Phase 4 8
First in 1980; this study’s year is marked. 64 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 70 is above the median of 54 across 2,552 interventional studies indexed under Ovarian Neoplasms.
Median enrollment 47 across the 1,497 interventional studies, 176 across the 195 observational. Of the 1,208 that completed or were terminated, 445 (37%) have results posted.
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712 of 1,778 have an industry lead sponsor. The 10 most frequent:
Weill Medical College of Cornell University is the lead sponsor of 892 studies on the registry; 165 are open to participants now.
Of its 123 completed or terminated interventional studies of FDA-regulated products, 94 (76%) have results posted.
Weill Medical College of Cornell University has 3 studies filed under Ovarian Neoplasms — fewer than ten, so there is no comparison to draw.
163 of the studies in Ovarian Neoplasms with a site in United States that are under way reach primary completion within a year, 9 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03815643Phase 3EMD Serono Research & Development Institute, Inc.Avelumab Program Rollover Study | 2026-11-24 |
| NCT05281471Phase 3Genelux CorporationEfficacy & Safety of Olvi-Vec and Platinum-doublet + Bevacizumab Compared to Physician's Choice of Chemotherapy and Bevacizumab in Platinum-Resistant/Refractory Ovarian Cancer (PRROC) (OnPrime, GOG-3076) | 2026-12 |
| NCT04498117Phase 3CanariaBio Inc.Oregovomab Plus Chemo in Newly Diagnosed Patients With Advanced Epithelial Ovarian Cancer Following Optimal Debulking Surgery | 2026-12-26 |
| NCT05059522Phase 3PfizerContinued Access Study for Participants Deriving Benefit in Pfizer-Sponsored Avelumab Parent Studies That Are Closing | 2026-12-31 |
| NCT04095364Phase 3NRG OncologyLetrozole With or Without Paclitaxel and Carboplatin in Treating Patients With Stage II-IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer | 2027-02-01 |
Add all 163 to your calendar (.ics) → With an account.
Among the 1,778 studies in Ovarian Neoplasms with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The goal of this clinical study is to evaluate the feasibility and acceptability of the Galleri multi-cancer early detection blood test in people with BRCA1 or BRCA2 gene changes who are at high risk for ovarian cancer. The study will also explore how well the test detects ovarian cancer or related precancerous conditions.
The main questions it aims to answer are:
Participants will:
This is a prospective, multi-center, mixed-methods feasibility study evaluating the integration of the Galleri multi-cancer early detection (MCED) liquid biopsy into hereditary cancer risk management for individuals at increased risk of epithelial ovarian cancer due to pathogenic or likely pathogenic BRCA1 or BRCA2 variants. The study also includes individuals with a prior diagnosis of serous tubal intraepithelial carcinoma (STIC), a precursor lesion associated with an increased risk of subsequent ovarian, fallopian tube, or primary peritoneal cancer.
The primary objective is to evaluate the feasibility of incorporating liquid biopsy testing into clinical care. Secondary objectives include evaluating participant acceptability, identifying barriers and facilitators to implementation, and generating preliminary data to inform a future large-scale validation study. Exploratory analyses will evaluate the relationship between liquid biopsy results and surgical pathology findings, including estimates of sensitivity, specificity, positive predictive value, negative predictive value, and concordance when feasible.
The study consists of two cohorts:
Cohort A (Surgical Feasibility Cohort):
Approximately 50 adults with BRCA1 or BRCA2 pathogenic variants who are undergoing planned risk-reducing gynecologic surgery at Weill Cornell Medicine or MD Anderson Cancer Center will receive the Galleri blood test within 7 days before surgery. Liquid biopsy results will be compared with surgical pathology findings to evaluate the feasibility of integrating blood-based cancer detection into hereditary cancer prevention. Participants will remain on their planned standard-of-care clinical pathway, and no additional surgical procedures will be performed for research purposes.
Cohort B (Exploratory STIC Cohort):
Up to 20 adults with a previous diagnosis of STIC will undergo baseline and annual Galleri blood testing for up to 10 years. The study will evaluate the feasibility and acceptability of long-term blood-based surveillance and descriptively characterize longitudinal liquid biopsy findings and clinical outcomes.
A subset of approximately 20-30 participants from Cohort A will complete semi-structured interviews or focus groups within six months of surgery. Interviews will be guided by Levesque's Healthcare Access Framework to explore participant perceptions, trust, barriers, facilitators, and implementation considerations related to liquid biopsy testing. Findings will help inform equitable implementation of future ovarian cancer early detection strategies.
The Galleri test used in this study is an investigational in vitro diagnostic device performed in a CLIA-certified laboratory. It is not approved by the U.S. Food and Drug Administration for ovarian cancer screening or this specific indication and is being evaluated for research purposes only.
Results from this feasibility study are intended to support the development of a future multi-site validation study evaluating the diagnostic performance of liquid biopsy for early detection of epithelial ovarian cancer in individuals with hereditary cancer susceptibility.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Cohort A participants must meet all of the following criteria:
Willing and able to provide 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:
Exclusion Criteria:
Cohort A:
Cohort B:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorized to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorized to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cohort A: Participants with pathogenic or likely pathogenic BRCA1/2 variants undergoing planned risk-reducing gynecologic surgery who receive the Galleri multi-cancer early detection blood test within 7 days before surgery. Liquid biopsy results will be correlated with surgical pathology findings.
Device: Galleri Multi-Cancer Early Detection (MCED) Blood Test
Cohort B: Participants with a prior diagnosis of serous tubal intraepithelial carcinoma (STIC) who receive the Galleri multi-cancer early detection blood test at baseline and annually for up to 10 years as part of longitudinal surveillance.
Device: Galleri Multi-Cancer Early Detection (MCED) Blood Test
Participants will undergo blood collection for the Galleri multi-cancer early detection (MCED) test, an investigational in vitro diagnostic device performed in a CLIA-certified laboratory. Results will be evaluated for feasibility, acceptability, and exploratory diagnostic performance for early detection of epithelial ovarian cancer in high-risk individuals.
Feasibility of Galleri testing in BRCA1/2 surgical cohort A
Proportion of eligible BRCA1/2 PV patients in Cohort A who successfully complete liquid biopsy testing within 7 days before risk-reducing gynecologic surgery, with corresponding surgical pathology available for correlation.
Time frame: Within 7 days before surgery
Feasibility of annual Galleri testing in STIC cohort B
Proportion of Cohort B patients who continue with annual liquid biopsy following diagnosis of STIC lesion for 10 years following STIC lesion diagnosis
Time frame: Up to 10 years
Participant-Reported Perceptions Regarding Liquid Biopsy
This portion of the semi-structured participant interviews and focus groups will explore perceptions regarding liquid biopsy for early detection of epithelial ovarian cancer, guided by Levesque's Healthcare Access Framework. Participants will complete semi-structured interviews or focus groups. Qualitative thematic analysis will be conducted. The identified themes will be reported, and the outcome measure will be the number of participants who endorsed each identified theme.
Time frame: One 45-60-minute interview or focus group conducted within 6 months following the participant's surgery.
Participant-Reported Barriers Regarding Liquid Biopsy
This portion of the semi-structured participant interviews and focus groups will explore barriers regarding liquid biopsy for early detection of epithelial ovarian cancer, guided by Levesque's Healthcare Access Framework. Participants will complete semi-structured interviews or focus groups. Qualitative thematic analysis will be conducted. The identified themes will be reported, and the outcome measure will be the number of participants who endorsed each identified theme.
Time frame: One 45-60-minute interview or focus group conducted within 6 months following the participant's surgery.
Participant-Reported Facilitators Regarding Liquid Biopsy
This portion of the semi-structured participant interviews and focus groups will explore facilitators regarding liquid biopsy for early detection of epithelial ovarian cancer, guided by Levesque's Healthcare Access Framework. Participants will complete semi-structured interviews or focus groups. Qualitative thematic analysis will be conducted. The identified themes will be reported, and the outcome measure will be the number of participants who endorsed each identified theme.
Time frame: One 45-60-minute interview or focus group conducted within 6 months following the participant's surgery.
Participant-Reported Acceptability Regarding Liquid Biopsy
This portion of the semi-structured participant interviews and focus groups will explore acceptability regarding liquid biopsy for early detection of epithelial ovarian cancer, guided by Levesque's Healthcare Access Framework. Participants will complete semi-structured interviews or focus groups. Qualitative thematic analysis will be conducted. The identified themes will be reported, and the outcome measure will be the number of participants who endorsed each identified theme.
Time frame: One 45-60-minute interview or focus group conducted within 6 months following the participant's surgery.
Participant-Reported Trust Regarding Liquid Biopsy
This portion of the semi-structured participant interviews and focus groups will explore trust regarding liquid biopsy for early detection of epithelial ovarian cancer, guided by Levesque's Healthcare Access Framework. Participants will complete semi-structured interviews or focus groups. Qualitative thematic analysis will be conducted. The identified themes will be reported, and the outcome measure will be the number of participants who endorsed each identified theme.
Time frame: One 45-60-minute interview or focus group conducted within 6 months following the participant's surgery.
Detection of non-ovarian cancer signals via liquid biopsy in Cohort A
Rates of detection of non-ovarian cancer signals via liquid biopsy in cohort A.
Time frame: Up to 10 years
Sensitivity of liquid biopsy for the detection of epithelial ovarian cancer (EOC) based on surgical pathology results for Cohort A
Sensitivity will be reported as the proportion of Cohort A participants with a positive surgical pathology result who have a positive liquid biopsy result. Liquid biopsy results will be compared with final surgical pathology findings.
Time frame: At the time of surgical pathology review (approximately 6 months).
Specificity of liquid biopsy for the detection of epithelial ovarian cancer (EOC) based on surgical pathology results for Cohort A
Specificity will be reported as the proportion of Cohort A participants with a negative surgical pathology result who have a negative liquid biopsy result. Liquid biopsy results will be compared with final surgical pathology findings.
Time frame: At the time of surgical pathology review (approximately 6 months).
PPV of diagnostic performance in Cohort A
Positive predictive value (NPV) of liquid biopsy for the detection of epithelial ovarian cancer (EOC) based on surgical pathology results for Cohort A.
Time frame: At the time of surgical pathology review (approximately 6 months).
NPV of diagnostic performance in Cohort A
Negative predictive value (NPV) of liquid biopsy for the detection of epithelial ovarian cancer (EOC) based on surgical pathology results for Cohort A.
Time frame: At the time of surgical pathology review (approximately 6 months).
Identified source of non-ovarian cancer signal following diagnostic evaluation in Cohort A
The identified source of the non-ovarian cancer signal in Cohort A participants, when determined through subsequent standard-of-care diagnostic evaluation (e.g., findings from physical examinations, imaging, laboratory testing, and other clinically indicated evaluations).
Time frame: Approximately 6 months after enrollment.
Findings of diagnostic evaluations following detection of a non-ovarian cancer signal in Cohort A
Findings from subsequent standard-of-care diagnostic evaluations performed in Cohort A participants following detection of a non-ovarian cancer signal by liquid biopsy, including findings from physical examinations, imaging, laboratory testing, and other clinically indicated evaluations.
Time frame: Approximately 6 months after enrollment.
Liquid biopsy completion in STIC cohort B at baseline
For Cohort B, the proportion of participants completing the baseline liquid biopsy at study enrollment.
Time frame: Baseline (study enrollment)
Change from baseline in liquid biopsy completion in STIC Cohort B at 1 year
For Cohort B, the proportion of participants completing the baseline liquid biopsy at 1 year.
Time frame: 1 year after enrollment
Change from baseline in liquid biopsy completion in STIC Cohort B at 2 years
For Cohort B, the proportion of participants completing the baseline liquid biopsy at 2 years.
Time frame: 2 years after enrollment
Change from baseline in liquid biopsy completion in STIC Cohort B at 3 years
For Cohort B, the proportion of participants completing the baseline liquid biopsy at 3 years.
Time frame: 3 years after enrollment
Change from baseline in liquid biopsy completion in STIC Cohort B at 4 years
For Cohort B, the proportion of participants completing the baseline liquid biopsy at 4 years.
Time frame: 4 years after enrollment
Change from baseline in liquid biopsy completion in STIC Cohort B at 5 years
For Cohort B, the proportion of participants completing the baseline liquid biopsy at 5 years.
Time frame: 5 years after enrollment
Change from baseline in liquid biopsy completion in STIC Cohort B at 6 years
For Cohort B, the proportion of participants completing the baseline liquid biopsy at 6 years.
Time frame: 6 years after enrollment
Change from baseline in liquid biopsy completion in STIC Cohort B at 7 years
For Cohort B, the proportion of participants completing the baseline liquid biopsy at 7 years.
Time frame: 7 years after enrollment
Change from baseline in liquid biopsy completion in STIC Cohort B at 8 years
For Cohort B, the proportion of participants completing the baseline liquid biopsy at 8 years.
Time frame: 8 years after enrollment
Change from baseline in liquid biopsy completion in STIC Cohort B at 9 years
For Cohort B, the proportion of participants completing the baseline liquid biopsy at 9 years.
Time frame: 9 years after enrollment
Change from baseline in liquid biopsy completion in STIC Cohort B at 10 years
For Cohort B, the proportion of participants completing the baseline liquid biopsy at 10 years.
Time frame: 10 years after enrollment
Overall participant retention over the 10-year follow-up period in STIC Cohort B
Proportion of Cohort B participants remaining in the study over the 10-year follow-up period.
Time frame: Up to 10 years after enrollment.
Plan to share: No
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Start is estimated for Oct 2026; primary completion for Oct 2039, 156 months later.
Of 282 non-industry interventional studies with no phase under Ovarian Neoplasms, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 76. This study's planned 156 months is above that.
Counting every sponsor, half of 293 studies reached it within 46 months; a quarter within 23 and three quarters within 76.
Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 16, 2026: start Sep 2026 → Oct 2026, primary completion Jul 2039 → Oct 2039 and completion Jul 2039 → Oct 2039.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Weill Medical College of Cornell University →