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NCT04917744 Clinical Trial

Metabolite Levels in Ovarian Cancer Patients Receiving Maintenance PARP Inhibitors

Ovarian Carcinoma Clinical Trial

Official title:
Longitudinal Metabolite Levels in Patients Receiving Maintenance PARP Inhibitors

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04917744
Other study ID # 20-013191
Secondary ID NCI-2021-0215120
Status Active, not recruiting
Phase
First received
Last updated
Start date April 1, 2021
Est. completion date March 19, 2025

Study information
Verified date September 2023
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 15
Est. completion date March 19, 2025
Est. primary completion date September 19, 2024
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Biospecimen Collection
Undergo collection of blood samples
Other:
• Laboratory Biomarker Analysis
Ancillary studies
• Medical Chart Review
Review of medical charts

Locations
Country Name City State
United States Mayo Clinic in Rochester Rochester Minnesota

Sponsors (1)
Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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) At four weeks post PARP inhibitor treatment
Secondary 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. Up to 2 years
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