Metabolite Levels in Ovarian Cancer Patients Receiving Maintenance PARP Inhibitors

NCT ID: NCT04917744

Last Updated: 2025-04-03

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

COMPLETED

Total Enrollment

5 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-04-01

Study Completion Date

2024-02-17

Brief Summary

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This study evaluates blood samples and compares levels of metabolites (levels of vitamins, carbohydrates, proteins, etc., that are in the blood), before and after the plasma exchange in patients scheduled to receive immunotherapy for their ovarian cancer. The information gained from this study may help researchers better understand the side effects from each treatment and possibly lessen those side effects for future treatments.

Detailed Description

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PRIMARY OBJECTIVE:

I. To determine the extent to which PARP inhibitor (PARPi) treatment reduces systemic levels of mesenchymal stem cell (MSC)-derived cancer support factors in patients with cancer.

OUTLINE:

Patients undergo collection of blood samples prior to drug initiation, weekly thereafter for the first month of therapy, monthly for the first month, and at disease progression or after cessation of treatment to monitor for toxicity. Blood samples are analyzed. Patients' medical charts are also reviewed to determine outcomes after PARP inhibition.

Conditions

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Ovarian Carcinoma

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Ancillary-correlative (blood collection, chart review)

Patients undergo collection of blood samples prior to drug initiation, weekly thereafter for the first month of therapy, monthly for the first month, and at disease progression or after cessation of treatment to monitor for toxicity. Blood samples are analyzed. Patients' medical charts are also reviewed to determine outcomes after PARP inhibition.

Biospecimen Collection

Intervention Type PROCEDURE

Undergo collection of blood samples

Laboratory Biomarker Analysis

Intervention Type OTHER

Ancillary studies

Medical Chart Review

Intervention Type OTHER

Review of medical charts

Interventions

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Biospecimen Collection

Undergo collection of blood samples

Intervention Type PROCEDURE

Laboratory Biomarker Analysis

Ancillary studies

Intervention Type OTHER

Medical Chart Review

Review of medical charts

Intervention Type OTHER

Other Intervention Names

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Chart Review

Eligibility Criteria

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Inclusion Criteria

* Adults
* Patients with ovarian cancer starting PARP inhibitor treatment

Exclusion Criteria

* Patients unwilling to return for blood draws, patients unwilling to continue PARP inhibitor treatment for at least one month
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jacob J. Orme, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic in Rochester

Locations

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Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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NCI-2021-02151

Identifier Type: REGISTRY

Identifier Source: secondary_id

20-013191

Identifier Type: OTHER

Identifier Source: secondary_id

20-013191

Identifier Type: -

Identifier Source: org_study_id

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