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Collection of Blood in Studying Metabolites in Patients With Prostate Cancer

Sponsor
University of Southern California (Other)
Overall Status
Recruiting
CT.gov ID
NCT03485794
Collaborator
National Cancer Institute (NCI) (NIH)
10
Enrollment
1
Location
72
Anticipated Duration (Months)
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

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

Detailed Description

PRIMARY OBJECTIVES:

  1. 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.

  2. Optimize data analysis methods and software usage to create a metabolic profile for patients at the time of blood collection.

  3. Compare metabolite profiles of isolated PBMCs versus (vs.) other blood fractions (plasma, red blood cells [RBCs], and whole blood).

  4. 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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
10 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Metabolic Profiling of Peripheral Blood Mononuclear Cells (PBMCs) by LC-MS in Prostate Cancer Patients
Actual Study Start Date :
Nov 14, 2017
Anticipated Primary Completion Date :
Nov 14, 2022
Anticipated Study Completion Date :
Nov 14, 2023

Arms and Interventions

Arm Intervention/Treatment
Diagnostic (biospecimen collection)

Patients undergo collection of blood for metabolic profiling via LC/Q-TOF/MS.

Procedure: Biospecimen Collection
Undergo collection of blood

Other: Laboratory Biomarker Analysis
Correlative studies

Outcome Measures

Primary Outcome Measures

  1. Blood sample collection [Baseline]

    The blood will be used to analyze the metabolites produced by white blood cells.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 USC / Norris Comprehensive Cancer Center Los Angeles California United States 90033

Sponsors and Collaborators

  • University of Southern California
  • National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Jonathan Katz, Ph.D., University of Southern California

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Southern California
ClinicalTrials.gov Identifier:
NCT03485794
Other Study ID Numbers:
  • 4P-17-8
  • NCI-2017-02078
  • 4P-17-8
  • P30CA014089
First Posted:
Apr 2, 2018
Last Update Posted:
Nov 18, 2021
Last Verified:
Nov 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:
Prostatic Neoplasms

Study Results

No Results Posted as of Nov 18, 2021