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Ovarian Cancer Liquid Biopsy for Early Assessment & Detection in Individuals With BRCA1/2 Pathogenic Variants (OC-LEAD)

2026年9月10日 更新者：Weill Medical College of Cornell University

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:

  • 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.

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

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 on the day of 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.

研究类型

介入性

注册 (估计的)

70

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 美国
    • New York
      • New York、New York、美国、10065
        • Weill Cornell Medicine
        • 接触：
        • 首席研究员：
          • Melissa K Frey, MD, MS
    • Texas
      • Houston、Texas、美国、77030
        • MD Anderson Cancer Center
        • 接触：
        • 首席研究员：
          • Jose A Rauh-Hain, MD, MS

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：诊断
  • 分配：非随机化
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Cohort A: BRCA1/2 Surgical Feasibility Cohort
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 on the day of surgery. Liquid biopsy results will be correlated with surgical pathology findings.
设备：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.
实验性的：Cohort B: STIC Longitudinal Surveillance Cohort
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.
设备：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.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Feasibility of Galleri testing in BRCA1/2 surgical cohort A
大体时间：Day of surgery (up to 1 day)
Proportion of eligible BRCA1/2 PV patients in Cohort A who successfully complete liquid biopsy testing day of risk-reducing gynecologic surgery, with corresponding surgical pathology available for correlation.
Day of surgery (up to 1 day)
Feasibility of annual Galleri testing in STIC cohort B
大体时间：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
Up to 10 years

次要结果测量

结果测量
措施说明
大体时间
Participant-Reported Perceptions Regarding Liquid Biopsy
大体时间：One 45-60-minute interview or focus group conducted within 6 months following the participant's surgery.
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.
One 45-60-minute interview or focus group conducted within 6 months following the participant's surgery.
Participant-Reported Barriers Regarding Liquid Biopsy
大体时间：One 45-60-minute interview or focus group conducted within 6 months following the participant's surgery.
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.
One 45-60-minute interview or focus group conducted within 6 months following the participant's surgery.
Participant-Reported Facilitators Regarding Liquid Biopsy
大体时间：One 45-60-minute interview or focus group conducted within 6 months following the participant's surgery.
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.
One 45-60-minute interview or focus group conducted within 6 months following the participant's surgery.
Participant-Reported Acceptability Regarding Liquid Biopsy
大体时间：One 45-60-minute interview or focus group conducted within 6 months following the participant's surgery.
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.
One 45-60-minute interview or focus group conducted within 6 months following the participant's surgery.
Participant-Reported Trust Regarding Liquid Biopsy
大体时间：One 45-60-minute interview or focus group conducted within 6 months following the participant's surgery.
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.
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
大体时间：Up to 10 years
Rates of detection of non-ovarian cancer signals via liquid biopsy in cohort A.
Up to 10 years
Sensitivity of liquid biopsy for the detection of epithelial ovarian cancer (EOC) based on surgical pathology results for Cohort A
大体时间：At the time of surgical pathology review (approximately 6 months).
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.
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
大体时间：At the time of surgical pathology review (approximately 6 months).
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.
At the time of surgical pathology review (approximately 6 months).
PPV of diagnostic performance in Cohort A
大体时间：At the time of surgical pathology review (approximately 6 months).
Positive predictive value (NPV) of liquid biopsy for the detection of epithelial ovarian cancer (EOC) based on surgical pathology results for Cohort A.
At the time of surgical pathology review (approximately 6 months).
NPV of diagnostic performance in Cohort A
大体时间：At the time of surgical pathology review (approximately 6 months).
Negative predictive value (NPV) of liquid biopsy for the detection of epithelial ovarian cancer (EOC) based on surgical pathology results for Cohort A.
At the time of surgical pathology review (approximately 6 months).
Identified source of non-ovarian cancer signal following diagnostic evaluation in Cohort A
大体时间：Approximately 6 months after enrollment.
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).
Approximately 6 months after enrollment.
Findings of diagnostic evaluations following detection of a non-ovarian cancer signal in Cohort A
大体时间：Approximately 6 months after enrollment.
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.
Approximately 6 months after enrollment.
Liquid biopsy completion in STIC cohort B at baseline
大体时间：Baseline (study enrollment)
For Cohort B, the proportion of participants completing the baseline liquid biopsy at study enrollment.
Baseline (study enrollment)
Change from baseline in liquid biopsy completion in STIC Cohort B at 1 year
大体时间：1 year after enrollment
For Cohort B, the proportion of participants completing the baseline liquid biopsy at 1 year.
1 year after enrollment
Change from baseline in liquid biopsy completion in STIC Cohort B at 2 years
大体时间：2 years after enrollment
For Cohort B, the proportion of participants completing the baseline liquid biopsy at 2 years.
2 years after enrollment
Change from baseline in liquid biopsy completion in STIC Cohort B at 3 years
大体时间：3 years after enrollment
For Cohort B, the proportion of participants completing the baseline liquid biopsy at 3 years.
3 years after enrollment
Change from baseline in liquid biopsy completion in STIC Cohort B at 4 years
大体时间：4 years after enrollment
For Cohort B, the proportion of participants completing the baseline liquid biopsy at 4 years.
4 years after enrollment
Change from baseline in liquid biopsy completion in STIC Cohort B at 5 years
大体时间：5 years after enrollment
For Cohort B, the proportion of participants completing the baseline liquid biopsy at 5 years.
5 years after enrollment
Change from baseline in liquid biopsy completion in STIC Cohort B at 6 years
大体时间：6 years after enrollment
For Cohort B, the proportion of participants completing the baseline liquid biopsy at 6 years.
6 years after enrollment
Change from baseline in liquid biopsy completion in STIC Cohort B at 7 years
大体时间：7 years after enrollment
For Cohort B, the proportion of participants completing the baseline liquid biopsy at 7 years.
7 years after enrollment
Change from baseline in liquid biopsy completion in STIC Cohort B at 8 years
大体时间：8 years after enrollment
For Cohort B, the proportion of participants completing the baseline liquid biopsy at 8 years.
8 years after enrollment
Change from baseline in liquid biopsy completion in STIC Cohort B at 9 years
大体时间：9 years after enrollment
For Cohort B, the proportion of participants completing the baseline liquid biopsy at 9 years.
9 years after enrollment
Change from baseline in liquid biopsy completion in STIC Cohort B at 10 years
大体时间：10 years after enrollment
For Cohort B, the proportion of participants completing the baseline liquid biopsy at 10 years.
10 years after enrollment
Overall participant retention over the 10-year follow-up period in STIC Cohort B
大体时间：Up to 10 years after enrollment.
Proportion of Cohort B participants remaining in the study over the 10-year follow-up period.
Up to 10 years after enrollment.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Weill Medical College of Cornell University

合作者

M.D. Anderson Cancer Center

调查人员

  • 首席研究员：Melissa K Frey, MD, MS、Weill Medical College of Cornell University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年9月1日

初级完成 (估计的)

2039年7月1日

研究完成 (估计的)

2039年7月1日

研究注册日期

首次提交

2026年8月10日

首先提交符合 QC 标准的

2026年8月10日

首次发布 (实际的)

2026年8月14日

研究记录更新

最后更新发布 (实际的)

2026年9月11日

上次提交的符合 QC 标准的更新

2026年9月10日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 26-02029818

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

是的

在美国制造并从美国出口的产品

不

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