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NCT03485794 Clinical Trial

Collection of Blood in Studying Metabolites in Patients With Prostate Cancer

Prostate Carcinoma Clinical Trial

Official title:
Metabolic Profiling of Peripheral Blood Mononuclear Cells (PBMCs) by LC-MS in Prostate Cancer Patients

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03485794
Other study ID # 4P-17-8
Secondary ID NCI-2017-020784P
Status Recruiting
Phase
First received
Last updated
Start date November 14, 2017
Est. completion date November 14, 2026

Study information
Verified date March 2024
Source University of Southern California
Contact Brandi Scott
Phone 310-272-7653
Email Brandi.Scott@med.usc.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This pilot research trial utilizes the collection of blood in studying metabolites in patients with prostate cancer. Metabolites are the small molecule products of cellular metabolism that are produced naturally in all living cells. Collecting blood in order to study metabolites may help doctors monitor and treat prostate cancer more effectively.

Description:

PRIMARY OBJECTIVES: I. Develop blood sample collection and preparation procedures for reliable, meaningful metabolomic profiling of peripheral blood mononuclear cells (PBMCs) by liquid chromatography/quadruple-time of flight/mass spectrometry (LC/Q-TOF/MS) that can be implemented in a clinical setting. II. Optimize data analysis methods and software usage to create a metabolic profile for patients at the time of blood collection. III. Compare metabolite profiles of isolated PBMCs versus (vs.) other blood fractions (plasma, red blood cells [RBCs], and whole blood). IV. Identify elements of the PBMC metabolite profile that may correlate to patient disease state. OUTLINE: Patients undergo collection of blood for metabolic profiling via LC/Q-TOF/MS.

Recruitment information / eligibility
Status Recruiting
Enrollment 10
Est. completion date November 14, 2026
Est. primary completion date November 14, 2025
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility Inclusion Criteria: - All subjects will have histologically confirmed prostate cancer - Provide written consent/authorization to participate in this study - Have no signs or symptoms of active infection - Exhibit a willingness to comply with the experimental procedures as outlined in this protocol

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Biospecimen Collection
Undergo collection of blood
Other:
• Laboratory Biomarker Analysis
Correlative studies

Locations
Country Name City State
United States USC / Norris Comprehensive Cancer Center Los Angeles California

Sponsors (2)
Lead Sponsor Collaborator
University of Southern California National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Blood sample collection The blood will be used to analyze the metabolites produced by white blood cells. Baseline
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