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

10. září 2026 aktualizováno: 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.

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Intervenční

Zápis (Odhadovaný)

70

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní místa

  • Spojené státy
    • New York
      • New York, New York, Spojené státy, 10065
        • Weill Cornell Medicine
        • Kontakt:
        • Vrchní vyšetřovatel:
          • Melissa K Frey, MD, MS
    • Texas
      • Houston, Texas, Spojené státy, 77030
        • MD Anderson Cancer Center
        • Kontakt:
        • Vrchní vyšetřovatel:
          • Jose A Rauh-Hain, MD, MS

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Diagnostický
  • Přidělení: Nerandomizované
  • Intervenční model: Přiřazení jedné skupiny
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: 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.
Přístroj: 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.
Experimentální: 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.
Přístroj: 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.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Feasibility of Galleri testing in BRCA1/2 surgical cohort A
Časové okno: 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
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Participant-Reported Perceptions Regarding Liquid Biopsy
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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.

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Weill Medical College of Cornell University

Spolupracovníci

M.D. Anderson Cancer Center

Vyšetřovatelé

  • Vrchní vyšetřovatel: Melissa K Frey, MD, MS, Weill Medical College of Cornell University

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

1. září 2026

Primární dokončení (Odhadovaný)

1. července 2039

Dokončení studie (Odhadovaný)

1. července 2039

Termíny zápisu do studia

První předloženo

10. srpna 2026

První předloženo, které splnilo kritéria kontroly kvality

10. srpna 2026

První zveřejněno (Aktuální)

14. srpna 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

11. září 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

10. září 2026

Naposledy ověřeno

1. září 2026

Více informací

Termíny související s touto studií

Klíčová slova

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Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

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