Predicting the Risk of Ovarian Cancer Recurrence Using Circulating Tumor DNA to Assess Residual Disease

NCT ID: NCT05212779

Last Updated: 2024-02-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

45 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-10-07

Study Completion Date

2024-12-30

Brief Summary

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Blood samples and Tumor tissue will be collected at certain timepoints and will be tested.

Detailed Description

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Blood samples will be tested by Natera to identify residual tumor DNA for genetic changes in the tumor to potentially improve prediction of long term prognosis and guide treatment options.

Conditions

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Epithelial Ovarian Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Females with Stage II-IV epithelial ovarian cancer

All patients, as participation requirements in this study, are required to have blood drawn at the completion of their adjuvant treatment. Blood sample should be collected within 6 weeks of receiving the last cycle of adjuvant chemotherapy.

Other optional time points which will be encouraged but not required:

1. After debulking surgery
2. Serial draws every 3 months while on maintenance or surveillance.

Signatera testing

Intervention Type DIAGNOSTIC_TEST

26mL blood for the first blood draw and tissue sample. 20mL blood all subsequent draws.

Altera Testing

Intervention Type DIAGNOSTIC_TEST

6ml blood and tissue sample.

Interventions

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Signatera testing

26mL blood for the first blood draw and tissue sample. 20mL blood all subsequent draws.

Intervention Type DIAGNOSTIC_TEST

Altera Testing

6ml blood and tissue sample.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

Clinical diagnosis of epithelial ovarian cancer stage II-IV

Exclusion Criteria

Insufficient tumor to perform Signatera testing; Inability to provide consent for the trial
Minimum Eligible Age

18 Years

Maximum Eligible Age

95 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

OTHER

Sponsor Role lead

Responsible Party

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John Nakayama, MD

PI

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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John Nakayama, MD

Role: PRINCIPAL_INVESTIGATOR

Allegheny Health Network

Locations

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AHN West Penn Hospital

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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Signatera

Identifier Type: -

Identifier Source: org_study_id

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