Galleri Multi-Cancer Early Detection (MCED) Blood Test / Ovarian Neoplasms / BRCA 2 Gene Mutation · Interventional Study

Ovarian Cancer Liquid Biopsy for Early Assessment & Detection in Individuals With BRCA1/2 Pathogenic Variants

ClinicalTrials.gov · August 14, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a registry record for a planned feasibility and acceptability study of the Galleri multi-cancer early detection blood test in BRCA1/2 carriers at high risk for ovarian cancer. No results are reported. The trial aims to evaluate incorporation into clinical care, participant acceptance, and detection accuracy for ovarian cancer and precancerous conditions, but these outcomes remain to be conducted and published.

What was studied

Interventional, Non Randomized, Single Group, Open label, Diagnostic purpose. Ovarian Neoplasms, BRCA 1 Gene Mutation, BRCA 2 Gene Mutation, Serous Tubal Intraepithelial Carcinoma, Early Detection of Ovarian Cancer; Female; age from 35 Years. Intervention: Cohort A: BRCA1/2 Surgical Feasibility Cohort; Cohort B: STIC Longitudinal Surveillance Cohort. n = 70. 2 sites: United States.

Key findings

Safety

Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.

Who this may help

This study is not yet recruiting and has not generated results. Clinicians should not act on this record. When results are published, they may inform whether Galleri testing is feasible and acceptable in BRCA1/2 carriers undergoing risk-reduction surgery or surveillance.

Plain-language summary

This is a study registration for a planned interventional feasibility trial with no results posted; it describes design and enrollment targets only, not outcomes or efficacy data.

Study design

As stated by the source record.

MethodsPrimary outcome measures: Feasibility of Galleri testing in BRCA1/2 surgical cohort A (assessed at Day of surgery (up to 1 day)); Feasibility of annual Galleri testing in STIC cohort B (assessed at Up to 10 years)

DesignInterventional, Non Randomized, Single Group, Open label, Diagnostic purpose

PopulationOvarian Neoplasms, BRCA 1 Gene Mutation, BRCA 2 Gene Mutation, Serous Tubal Intraepithelial Carcinoma, Early Detection of Ovarian Cancer; Female; age from 35 Years

Sample size70

InterventionCohort A: BRCA1/2 Surgical Feasibility Cohort; Cohort B: STIC Longitudinal Surveillance Cohort

Setting2 sites: United States

Reported figures

Quoted from the source exactly as published.

Estimated enrollment70

Primary outcome (Cohort A)Feasibility of Galleri testing in BRCA1/2 surgical cohort, measured at day of surgery (up to 1 day)

Primary outcome (Cohort B)Feasibility of annual Galleri testing in STIC cohort, measured up to 10 years

Clinical bottom line

Caveats

No results posted in this registry record; study is planned, not completed.
Primary outcomes are feasibility and acceptability, not diagnostic accuracy or clinical benefit.
Sample size (70) is modest and distributed across two cohorts; power for efficacy inference is unclear.
No control or comparator group is described; design does not include a comparative arm.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

moderate

Interventional feasibility study with two cohorts; no control arm specified.

Directness

moderate

Targets high-risk BRCA1/2 carriers; directly relevant population but feasibility primary outcome.

Consistency

insufficient

No results reported; consistency cannot be assessed from a registry record.

Risk of bias

insufficient

Study not yet recruiting; design quality and bias risk cannot be evaluated pre-launch.

Sample adequacy

limited

70 estimated participants across two cohorts; modest sample for efficacy inference.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT07764744). This is a study registration, not published results. Lead sponsor: Weill Medical College of Cornell University. Recruitment status: NOT_YET_RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 70 participants (ESTIMATED). Conditions: Ovarian Neoplasms, BRCA 1 Gene Mutation, BRCA 2 Gene Mutation, Serous Tubal Intraepithelial Carcinoma, Early Detection of Ovarian Cancer. Interventions: DEVICE: Galleri Multi-Cancer Early Detection (MCED) Blood Test. Primary outcome measures: Feasibility of Galleri testing in BRCA1/2 surgical cohort A , Day of surgery (up to 1 day); Feasibility of annual Galleri testing in STIC cohort B , Up to 10 years. Brief 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. 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.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

Galleri Multi-Cancer Early Detection (MCED) Blood TestOvarian NeoplasmsNCT07764744Weill Medical College of Cornell UniversityBRCA 2 Gene MutationBRCA 1 Gene Mutation