Ovarian Cancer Liquid Biopsy for Early Assessment & Detection (OC-LEAD)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Feasibility of Galleri testing in BRCA1/2 surgical cohort A
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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:
- •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
排除标准
- •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.
- •Inability to provide informed consent.
- •Concurrent participation in another interventional trial that may confound study outcomes.
- •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.
研究组 & 干预措施
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.
干预措施: Galleri Multi-Cancer Early Detection (MCED) Blood Test (Device)
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.
干预措施: Galleri Multi-Cancer Early Detection (MCED) Blood Test (Device)
结局指标
主要结局
Feasibility of Galleri testing in BRCA1/2 surgical cohort A
时间窗: 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.
Feasibility of annual Galleri testing in STIC cohort B
时间窗: 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
次要结局
- NPV of diagnostic performance in Cohort A(At the time of surgical pathology review (approximately 6 months).)
- Participant-Reported Perceptions Regarding Liquid Biopsy(One 45-60-minute interview or focus group conducted within 6 months following the participant's surgery.)
- Participant-Reported Barriers Regarding Liquid Biopsy(One 45-60-minute interview or focus group conducted within 6 months following the participant's surgery.)
- Participant-Reported Facilitators Regarding Liquid Biopsy(One 45-60-minute interview or focus group conducted within 6 months following the participant's surgery.)
- Participant-Reported Acceptability Regarding Liquid Biopsy(One 45-60-minute interview or focus group conducted within 6 months following the participant's surgery.)
- Participant-Reported Trust Regarding Liquid Biopsy(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(Up to 10 years)
- Sensitivity 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).)
- Specificity 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).)
- PPV of diagnostic performance in 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(Approximately 6 months after enrollment.)
- Findings of diagnostic evaluations following detection of a non-ovarian cancer signal in Cohort A(Approximately 6 months after enrollment.)
- Liquid biopsy completion in STIC cohort B at baseline(Baseline (study enrollment))
- Change from baseline in liquid biopsy completion in STIC Cohort B at 1 year(1 year after enrollment)
- Change from baseline in liquid biopsy completion in STIC Cohort B at 2 years(2 years after enrollment)
- Change from baseline in liquid biopsy completion in STIC Cohort B at 3 years(3 years after enrollment)
- Change from baseline in liquid biopsy completion in STIC Cohort B at 4 years(4 years after enrollment)
- Change from baseline in liquid biopsy completion in STIC Cohort B at 5 years(5 years after enrollment)
- Change from baseline in liquid biopsy completion in STIC Cohort B at 6 years(6 years after enrollment)
- Change from baseline in liquid biopsy completion in STIC Cohort B at 7 years(7 years after enrollment)
- Change from baseline in liquid biopsy completion in STIC Cohort B at 8 years(8 years after enrollment)
- Change from baseline in liquid biopsy completion in STIC Cohort B at 9 years(9 years after enrollment)
- Change from baseline in liquid biopsy completion in STIC Cohort B at 10 years(10 years after enrollment)
- Overall participant retention over the 10-year follow-up period in STIC Cohort B(Up to 10 years after enrollment.)