Clincosm LogoSign in Get a demo

Metabolite Levels in Ovarian Cancer Patients Receiving Maintenance PARP Inhibitors

Sponsor
Mayo Clinic (Other)
Overall Status
Recruiting
CT.gov ID
NCT04917744
Collaborator
National Cancer Institute (NCI) (NIH)
15
Enrollment
1
Location
35.6
Anticipated Duration (Months)
0.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Biospecimen Collection
  • Other: Laboratory Biomarker Analysis
  • Other: Medical Chart Review

Detailed Description

PRIMARY OBJECTIVE:
  1. 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 Design

Study Type:
Observational
Anticipated Enrollment :
15 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Longitudinal Metabolite Levels in Patients Receiving Maintenance PARP Inhibitors
Actual Study Start Date :
Apr 1, 2021
Anticipated Primary Completion Date :
Mar 19, 2023
Anticipated Study Completion Date :
Mar 19, 2024

Arms and Interventions

Arm Intervention/Treatment
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.

Procedure: Biospecimen Collection
Undergo collection of blood samples

Other: Laboratory Biomarker Analysis
Ancillary studies

Other: Medical Chart Review
Review of medical charts
Other Names:
  • Chart Review

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mayo Clinic in Rochester Rochester Minnesota United States 55905

    Sponsors and Collaborators

    • Mayo Clinic
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Jacob J Orme, Mayo Clinic in Rochester

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mayo Clinic
    ClinicalTrials.gov Identifier:
    NCT04917744
    Other Study ID Numbers:
    • 20-013191
    • NCI-2021-02151
    • 20-013191
    • P30CA015083
    First Posted:
    Jun 8, 2021
    Last Update Posted:
    Jul 18, 2022
    Last Verified:
    Jul 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Ovarian Neoplasms
    Carcinoma, Ovarian Epithelial

    Study Results

    No Results Posted as of Jul 18, 2022