Metabolite Levels in Ovarian Cancer Patients Receiving Maintenance PARP Inhibitors

NCT04917744 | Completed

• 2 other identifiers: 20-013191NCI-2021-02151
• Study Type: observational
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Ovarian Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Progression-free survival

  Up to 2 years

Study Arms (1)

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; Other: Laboratory Biomarker Analysis; Other: Medical Chart Review

Interventions

Biospecimen Collection PROCEDURE

Undergo collection of blood samples

Ancillary-correlative (blood collection, chart review)

Laboratory Biomarker Analysis OTHER

Ancillary studies

Ancillary-correlative (blood collection, chart review)

Medical Chart Review OTHER

Review of medical charts

Also known as: Chart Review

Ancillary-correlative (blood collection, chart review)

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with melanoma scheduled to receive immunotherapy for their ovarian cancer.

You may qualify if:

• Adults
• Patients with ovarian cancer starting PARP inhibitor treatment

You may not qualify if:

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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

Biospecimen

Retention: SAMPLES WITH DNA

Blood

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Jacob J. Orme, M.D., Ph.D.

  Mayo Clinic in Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2021
• First Posted: June 8, 2021
• Study Start: April 1, 2021
• Primary Completion: April 17, 2023
• Study Completion: February 17, 2024
• Last Updated: April 3, 2025

Record last verified: 2025-03

Locations

US (1)