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OpenTrials
Completed

NCT Number: NCT04917744

Metabolite Levels in Ovarian Cancer Patients Receiving Maintenance PARP Inhibitors

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.

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Key information

Conditions

Ovarian Carcinoma Adnexal Diseases Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Site Ovarian Diseases Ovarian Neoplasms Urogenital Diseases Urogenital Neoplasms

Sex eligibility

Female

Study type

Observational

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Biospecimen Collection

Procedure

Undergo collection of blood samples

laboratory biomarker analysis

Other

Ancillary studies

medical chart review

Other

Review of medical charts

Other names: Chart Review

Primary outcomes

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

    Time frame: 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 outcomes

  1. Progression-free survival

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Longitudinal Metabolite Levels in Patients Receiving Maintenance PARP Inhibitors

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Jun 8, 2021
Registry last updated
Apr 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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