Ovarian NeoplasmsOC-LEADNCT07764744
Ovarian Cancer Liquid Biopsy for Early Assessment & Detection in Individuals With BRCA1/2 Pathogenic Variants
A study testing Galleri Multi-Cancer Early Detection (MCED) Blood Test in people with Ovarian Neoplasms and BRCA 1 Gene Mutation, run by Weill Medical College of Cornell University at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 35 years and older, women only
- Conditions the study is for
- Ovarian Neoplasms, BRCA 1 Gene Mutation, BRCA 2 Gene Mutation
- What is being tested?
- Galleri Multi-Cancer Early Detection (MCED) Blood Test
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2026to Oct 2039
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cohort A participants must meet all of the following criteria:
- Age ≥ 35 years (based on current National Comprehensive Cancer Network guidelines35 for risk-reducing gynecologic surgery) with no upper age limit
- Confirmed germline PV or likely PV in the BRCA1 or BRCA2 genes, documented by CLIA-certified genetic testing.
- Scheduled to undergo risk-reducing gynecologic surgery (salpingo-oophorectomy or salpingectomy with or without hysterectomy) at the study site.
- 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:
Show all 10Show fewer
- Age ≥ 35 years with no upper age limit.
- STIC lesion previously identified on surgical pathology within the prior 10 years.
- Willing and able to undergo baseline and annual research blood draws for up to 10 years following STIC lesion diagnosis.
- Willing and able to provide informed consent in English
Who cannot join
- Cohort A:
- Pregnant or breastfeeding at the time of enrollment.
- Prior removal of bilateral fallopian tubes and/or bilateral ovaries.
- Active diagnosis of cancer.
- Prior or active diagnosis of epithelial ovarian, fallopian tube, or primary peritoneal cancer at the time of consent.
- Patients with a history of cancer are eligible when > 2 years no evidence of disease.
Show all 15Show fewer
- Inability to provide informed consent.
- Concurrent participation in another interventional trial that may confound study outcomes.
- Cohort B:
- Pregnant or breastfeeding at the time of enrollment.
- Active diagnosis of cancer.
- 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).
- Patients with a history of cancer are eligible when > 2 years no evidence of disease.
- Inability to provide informed consent.
- Concurrent participation in another interventional trial that may confound study outcomes.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
MD Anderson Cancer Center
Houston, Texas, 77030
Jose A Rauh-Hain, MD, 713-392-6161, JARauh@mdanderson.org
Jose A Rauh-Hain, MD, MS
Weill Cornell Medicine
New York, New York, 10065
Melissa K Frey, MD, MS, 646-697-6621, mkf2002@med.cornell.edu
Melissa K Frey, MD, MS
About this study
Official title: Ovarian Cancer Liquid Biopsy for Early Assessment & Detection (OC-LEAD)
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:
Read more
- Is it feasible to incorporate the Galleri blood test into the care of people at high * risk for ovarian cancer?
- Is the Galleri blood test acceptable to participants?
- How well does the Galleri blood test identify ovarian cancer or related precancerous conditions?
Participants will:
- Receive the Galleri blood test.
- Complete questionnaires about their experience with the test.
- Some participants will also complete an interview about their experiences and preferences.
- Continue with their planned standard medical care, including surgery or follow-up visits, as appropriate.
Read the detailed description
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.
- Conditions
- Ovarian Neoplasms, BRCA 1 Gene Mutation, BRCA 2 Gene Mutation, Serous Tubal Intraepithelial Carcinoma, Early Detection of Ovarian Cancer
- Being tested
- Galleri Multi-Cancer Early Detection (MCED) Blood Test
- Keywords
- Ovarian cancer, Liquid biopsy, Galleri, Multi-cancer early detection, BRCA1, BRCA2, Hereditary breast and ovarian cancer syndrome, Serous tubal intraepithelial carcinoma (STIC), Risk-reducing salpingo-oophorectomy, Early cancer detection, Hereditary cancer, Cancer screening, Implementation science
- Medical subject headings
- Ovarian Neoplasms, Hereditary Breast and Ovarian Cancer Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Galleri Multi-Cancer Early Detection (MCED) Blood TestDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Cohort A: BRCA1/2 Surgical Feasibility Cohort | Experimental | 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. Receives: Device: Galleri Multi-Cancer Early Detection (MCED) Blood Test |
| Cohort B: STIC Longitudinal Surveillance Cohort | Experimental | 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. Receives: Device: Galleri Multi-Cancer Early Detection (MCED) Blood Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: Up to 10 years
Secondary outcomes (24)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 10 years after enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2026
- Study startOct 2026 (estimated)
- Primary completionOct 2039 (estimated)
- Study completionOct 2039 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian NeoplasmsStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- This is a single-group, prospective, multi-center study in which all participants receive the Galleri multi-cancer early detection blood test. Participants are enrolled into one of two predefined cohorts based on clinical characteristics: (1) BRCA1/2 pathogenic variant carriers undergoing risk-reducing gynecologic surgery or (2) individuals with a prior diagnosis of serous tubal intraepithelial carcinoma (STIC) undergoing longitudinal surveillance. There is no randomization or comparator arm. Liquid biopsy results will be correlated with surgical pathology and/or longitudinal clinical outcomes, and a subset of participants will complete qualitative interviews.
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- M.D. Anderson Cancer Center
- Responsible party
- Sponsor
- Investigators
- Melissa K Frey, MD, MS, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07764744
- Sponsor's protocol ID
- 26-02029818
- Acronym
- OC-LEAD
- Status last verified
- Oct 2026
- First submitted
- 10 Aug 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ovarian Cancer Liquid Biopsy for Early Assessment & Detection (OC-LEAD)
- ClinicalTrials.gov ID
- NCT07764744
- Acronym / sponsor ID
- OC-LEAD / 26-02029818
- Conditions
- Ovarian Neoplasms, BRCA 1 Gene Mutation, BRCA 2 Gene Mutation, Serous Tubal Intraepithelial Carcinoma, Early Detection of Ovarian Cancer
- Keywords
- Ovarian cancer, Liquid biopsy, Galleri, Multi-cancer early detection, BRCA1, BRCA2, Hereditary breast and ovarian cancer syndrome, Serous tubal intraepithelial carcinoma (STIC)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- M.D. Anderson Cancer Center
- Study start
- Oct 2026 (estimated)
- Primary completion
- Oct 2039 (estimated)
- Study completion
- Oct 2039 (estimated)
- First posted
- 14 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Is it feasible to incorporate the Galleri blood test into the care of people at high * risk for ovarian cancer?
- Is the Galleri blood test acceptable to participants?
- How well does the Galleri blood test identify ovarian cancer or related precancerous conditions?
Participants will:
- Receive the Galleri blood test.
- Complete questionnaires about their experience with the test.
- Some participants will also complete an interview about their experiences and preferences.
- Continue with their planned standard medical care, including surgery or follow-up visits, as appropriate.
Detailed description
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a single-group, prospective, multi-center study in which all participants receive the Galleri multi-cancer early detection blood test. Participants are enrolled into one of two predefined cohorts based on clinical characteristics: (1) BRCA1/2 pathogenic variant carriers undergoing risk-reducing gynecologic surgery or (2) individuals with a prior diagnosis of serous tubal intraepithelial carcinoma (STIC) undergoing longitudinal surveillance. There is no randomization or comparator arm. Liquid biopsy results will be correlated with surgical pathology and/or longitudinal clinical outcomes, and a subset of participants will complete qualitative interviews.
| Arm | Type | Receives |
|---|---|---|
| Cohort A: BRCA1/2 Surgical Feasibility Cohort | Experimental | Device: Galleri Multi-Cancer Early Detection (MCED) Blood TestCohort 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. |
| Cohort B: STIC Longitudinal Surveillance Cohort | Experimental | Device: Galleri Multi-Cancer Early Detection (MCED) Blood TestCohort 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. |
Who may qualify
- Ages
- 35 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age ≥ 35 years (based on current National Comprehensive Cancer Network guidelines35 for risk-reducing gynecologic surgery) with no upper age limit
- Confirmed germline PV or likely PV in the BRCA1 or BRCA2 genes, documented by CLIA-certified genetic testing.
- Scheduled to undergo risk-reducing gynecologic surgery (salpingo-oophorectomy or salpingectomy with or without hysterectomy) at the study site.
- 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
- Age ≥ 35 years with no upper age limit.
Key exclusion criteria (15 listed)
- Pregnant or breastfeeding at the time of enrollment.
- Prior removal of bilateral fallopian tubes and/or bilateral ovaries.
- Active diagnosis of cancer.
- Prior or active diagnosis of epithelial ovarian, fallopian tube, or primary peritoneal cancer at the time of consent.
- Patients with a history of cancer are eligible when > 2 years no evidence of disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Galleri Multi-Cancer Early Detection (MCED) Blood TestParticipants 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. | Device | Cohort A: BRCA1/2 Surgical Feasibility Cohort, Cohort B: STIC Longitudinal Surveillance Cohort |
Primary outcome
Feasibility of Galleri testing in BRCA1/2 surgical cohort A
Time frame: Within 7 days before surgery
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.
Feasibility of annual Galleri testing in STIC cohort B
Time frame: Up to 10 years
Proportion of Cohort B patients who continue with annual liquid biopsy following diagnosis of STIC lesion for 10 years following STIC lesion diagnosis
24 secondary outcomes
Participant-Reported Perceptions Regarding Liquid Biopsy
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
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
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
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
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
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
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
Time frame: At the time of surgical pathology review (approximately 6 months).
PPV of diagnostic performance in Cohort A
Time frame: At the time of surgical pathology review (approximately 6 months).
NPV of diagnostic performance in 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
Time frame: Approximately 6 months after enrollment.
Findings of diagnostic evaluations following detection of a non-ovarian cancer signal in Cohort A
Time frame: Approximately 6 months after enrollment.
Liquid biopsy completion in STIC cohort B at baseline
Time frame: Baseline (study enrollment)
Change from baseline in liquid biopsy completion in STIC Cohort B at 1 year
Time frame: 1 year after enrollment
Change from baseline in liquid biopsy completion in STIC Cohort B at 2 years
Time frame: 2 years after enrollment
Change from baseline in liquid biopsy completion in STIC Cohort B at 3 years
Time frame: 3 years after enrollment
Change from baseline in liquid biopsy completion in STIC Cohort B at 4 years
Time frame: 4 years after enrollment
Change from baseline in liquid biopsy completion in STIC Cohort B at 5 years
Time frame: 5 years after enrollment
Change from baseline in liquid biopsy completion in STIC Cohort B at 6 years
Time frame: 6 years after enrollment
Change from baseline in liquid biopsy completion in STIC Cohort B at 7 years
Time frame: 7 years after enrollment
Change from baseline in liquid biopsy completion in STIC Cohort B at 8 years
Time frame: 8 years after enrollment
Change from baseline in liquid biopsy completion in STIC Cohort B at 9 years
Time frame: 9 years after enrollment
Change from baseline in liquid biopsy completion in STIC Cohort B at 10 years
Time frame: 10 years after enrollment
Overall participant retention over the 10-year follow-up period in STIC Cohort B
Time frame: Up to 10 years after enrollment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Melissa K Frey, MD, MS principal investigator
Weill Medical College of Cornell University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Galleri Multi-Cancer Early Detection (MCED) Blood Test in people with Ovarian Neoplasms and BRCA 1 Gene Mutation, run by Weill Medical College of Cornell University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Melissa K Frey, Study Official, MD, MS (646-697-6621, mkf2002@med.cornell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Galleri testing in BRCA1/2 surgical cohort A (time frame: Within 7 days before surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.