Collection of Blood in Studying Metabolites in Patients With Prostate Cancer

NCT ID: NCT03485794

Last Updated: 2025-08-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-11-14

Study Completion Date

2024-01-02

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Prostate Carcinoma

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Diagnostic (biospecimen collection)

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

Biospecimen Collection

Intervention Type PROCEDURE

Undergo collection of blood

Laboratory Biomarker Analysis

Intervention Type OTHER

Correlative studies

Interventions

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Biospecimen Collection

Undergo collection of blood

Intervention Type PROCEDURE

Laboratory Biomarker Analysis

Correlative studies

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

University of Southern California

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jonathan Katz, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Southern California

Locations

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USC / Norris Comprehensive Cancer Center

Los Angeles, California, United States

Site Status

Countries

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United States

Other Identifiers

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NCI-2017-02078

Identifier Type: REGISTRY

Identifier Source: secondary_id

4P-17-8

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA014089

Identifier Type: NIH

Identifier Source: secondary_id

View Link

4P-17-8

Identifier Type: -

Identifier Source: org_study_id

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