Metabolite Levels in Ovarian Cancer Patients Receiving Maintenance PARP Inhibitors

Active, not recruiting

• Conditions: Ovarian Carcinoma
• Interventions: Procedure: Biospecimen Collection; Other: Laboratory Biomarker Analysis; Other: Medical Chart Review

• Registration Number: NCT04917744
• Lead Sponsor: Mayo Clinic

Brief Summary

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

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.

Study Timeline

• Study Start: 2021-04-01
• Study First Submitted: 2021-06-02
• Study First Submitted QC: 2021-06-02
• Study First Posted: 2021-06-08
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-28
• Last Update Posted: 2023-10-02
• Primary Completion: 2024-09-19
• Study Completion: 2025-03-19

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 15

Inclusion Criteria

• Adults
• Patients with ovarian cancer starting PARP inhibitor treatment

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ancillary-correlative (blood collection, chart review)	Biospecimen Collection	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.
Ancillary-correlative (blood collection, chart review)	Laboratory Biomarker Analysis	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.
Ancillary-correlative (blood collection, chart review)	Medical 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.

Primary Outcome Measures

Name	Time	Method
Change of mesenchymal stem cell (MSC)-derived cancer support factors	At four weeks post PARP inhibitor treatment	Levels of MSC-derived cancer support factors will be compared to baseline (i.e. pre-PARPi therapy) at each collection time point by Student's t test. In addition, outcomes by Cox proportional hazards will be compared between designated responders (i.e. patients whose MSC-derived cancer support factors decreased after PARP inhibition) and non-responders (i.e. patients whose MSC-derived cancer support factors did not decrease after PARP inhibition)

Secondary Outcome Measures

Name	Time	Method
Progression-free survival	Up to 2 years	Stratified by extent of MSC-derived cancer support factor reduction. Will also compare levels at progression and/or after discontinuation of therapy.

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States