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

Ovarian Cancer Liquid Biopsy for Early Assessment & Detection (OC-LEAD)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
35 Years and older
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Blood draws, Questionnaires, Interviews, Biopsies

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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 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."
  • "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 primary objective is to evaluate the feasibility of incorporating liquid biopsy testing into clinical care."
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether the Galleri blood test is practical to use and acceptable to people at high risk for ovarian cancer. It also checks how well the test finds ovarian cancer or early cell changes that may lead to cancer. It includes people with certain BRCA1 or BRCA2 gene changes and people who had a STIC lesion, an early cancer-related change in the fallopian tube.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Both groups: Be age 35 or older, with no upper age limit.
  • Both groups: Be willing and able to give informed consent in English, meaning you understand and agree to join.
  • Group A: Have a confirmed inherited BRCA1 or BRCA2 gene change that is harmful or likely harmful, documented by a certified genetic testing lab.
  • Group A: Have surgery planned at the study site to lower cancer risk by removing the fallopian tubes, with or without the ovaries or womb.
  • Group B: Have had a STIC lesion found in tissue removed during surgery within the past 10 years.
  • Group B: Be willing and able to have a research blood draw at the start and each year for up to 10 years after the STIC diagnosis.

Who can't join

  • Both groups: Pregnant or breastfeeding when joining.
  • Both groups: Have cancer now.
  • Both groups: Have ever had epithelial ovarian cancer, which starts in the ovary's lining; fallopian tube cancer; or primary peritoneal cancer, which starts in the belly's lining. A past STIC lesion alone does not exclude Group B.
  • Both groups: Have had another cancer unless there has been no sign of disease for more than 2 years.
  • Both groups: Cannot give informed consent.
  • Both groups: Are in another study testing a treatment or procedure that could affect this study's results.
  • Group A only: Have already had both fallopian tubes, both ovaries, or both sets removed.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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.

Study sites (2)

NY

TX