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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.

調査の概要

状態

まだ募集していません

条件

介入・治療

詳細な説明

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.

研究の種類

介入

入学 (推定)

70

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

  • アメリカ
    • New York
      • New York、New York、アメリカ、10065
        • Weill Cornell Medicine
        • コンタクト：
        • 主任研究者：
          • Melissa K Frey, MD, MS
    • Texas
      • Houston、Texas、アメリカ、77030
        • MD Anderson Cancer Center
        • コンタクト：
        • 主任研究者：
          • Jose A Rauh-Hain, MD, MS

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：診断
  • 割り当て：非ランダム化
  • 介入モデル：単一グループの割り当て
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
実験的：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.
デバイス：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.
実験的：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.
デバイス：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.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Feasibility of Galleri testing in BRCA1/2 surgical cohort A
時間枠：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
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
Participant-Reported Perceptions Regarding Liquid Biopsy
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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.

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Weill Medical College of Cornell University

協力者

M.D. Anderson Cancer Center

捜査官

  • 主任研究者：Melissa K Frey, MD, MS、Weill Medical College of Cornell University

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年9月1日

一次修了 (推定)

2039年7月1日

研究の完了 (推定)

2039年7月1日

試験登録日

最初に提出

2026年8月10日

QC基準を満たした最初の提出物

2026年8月10日

最初の投稿 (実際)

2026年8月14日

学習記録の更新

投稿された最後の更新 (実際)

2026年9月11日

QC基準を満たした最後の更新が送信されました

2026年9月10日

最終確認日

2026年9月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • 26-02029818

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

はい

米国で製造され、米国から輸出された製品。

いいえ

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