Ovarian Carcinoma
Conditions
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.
Detailed 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.
Interventions
PROCEDUREBiospecimen Collection
Undergo collection of blood samples
OTHERLaboratory Biomarker Analysis
Ancillary studies
OTHERMedical Chart Review
Review of medical charts
Sponsors
Mayo Clinic
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed