Metabolite Levels in Ovarian Cancer Patients Receiving Maintenance PARP Inhibitors

Mayo Clinic5 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

Conditions

Ovarian Carcinoma

Interventions

Biospecimen CollectionPROCEDURE

Undergo collection of blood samples

Laboratory Biomarker AnalysisOTHER

Ancillary studies

Medical Chart ReviewOTHER

Review of medical charts

Eligibility

Sex: FEMALE

Medical Language ↔ Plain English

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

Locations (1)

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Outcomes

Primary Outcomes

Change of mesenchymal stem cell (MSC)-derived cancer support factors

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)

Time frame: At four weeks post PARP inhibitor treatment

Secondary Outcomes

Progression-free survival

Stratified by extent of MSC-derived cancer support factor reduction. Will also compare levels at progression and/or after discontinuation of therapy.

Time frame: Up to 2 years

Data from ClinicalTrials.gov

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