Analyses of Human Samples Collected in Clinical Trials

NCT ID: NCT00339664

Last Updated: 2020-03-30

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

COMPLETED

Total Enrollment

2579 participants

Study Classification

OBSERVATIONAL

Study Start Date

2003-07-02

Study Completion Date

2020-03-26

Brief Summary

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Cancer patients in clinical trials donate various human samples (e.g., serum, plasma, blood, urine, feces, bile, saliva) for research purposes.

The purpose of this study is to conduct further analyses on these existing samples from clinical trials that are being performed outside of, but in collaboration with, the National Cancer Institute.

Detailed Description

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Various human samples (e.g., serum, plasma, whole blood, erythrocytes, urine, feces, bile, and/or saliva) will be collected from cancer patients enrolled on approved clinical trials, in accordance with the local protocol. These trials are being conducted at outside institutions, in collaboration with the National Cancer Institute (NCI) and the samples will be sent to the NCI for pharmacological analysis, involving determination of parent drug and/or metabolite concentrations and subsequent pharmacokinetics and statistical data analysis. This study aims to further characterize the clinical pharmacokinetic behavior of select cancer therapeutics. Future collaborators will be added via the protocol amendment procedure.

Conditions

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Leukemia, Myeloid Neoplasm Metastasis Leukemia, Lymphoid Prostate Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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1/ patients

Patients on approved clinical trials

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

Any patients entered on approved trials of cancer therapeutics or agents that are commonly administered to patients with cancer at institutions outside of the intramural NCI are eligible for inclusion, provided that they have consented to pharmacological analysis in the original consent form.

Exclusion Criteria

None anticipated at this time.
Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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William D Figg, Pharm.D.

Role: PRINCIPAL_INVESTIGATOR

National Cancer Institute (NCI)

Locations

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Childrens National Medical Center

Washington D.C., District of Columbia, United States

Site Status

H. Lee Moffitt Cancer Center & Research Institute

Tampa, Florida, United States

Site Status

University of Chicago

Chicago, Illinois, United States

Site Status

University of Maryland, Baltimore

Baltimore, Maryland, United States

Site Status

Johns Hopkins Medical Center

Baltimore, Maryland, United States

Site Status

Sidney Kimmel Comprehensive Cancer Center

Baltimore, Maryland, United States

Site Status

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, United States

Site Status

Mayo Clinic, Rochester

Rochester, Minnesota, United States

Site Status

Case Western Reserve University

Cleveland, Ohio, United States

Site Status

University of Maryland at Amish Research Clinic, Lancaster

Lancaster, Pennsylvania, United States

Site Status

Abramson Cancer Center, University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Hillman Cancer Center at University of Pittsburg Cancer Institute

Pittsburgh, Pennsylvania, United States

Site Status

Hollings Cancer Center at Medical University of South Carolina

Charleston, South Carolina, United States

Site Status

McGuire Veterans Administration Medical Center

Richmond, Virginia, United States

Site Status

Massey Cancer Center, Virginia Commonwealth University

Richmond, Virginia, United States

Site Status

Leiden University Medical Center

Leiden, , Netherlands

Site Status

Erasmus Medical Center

Rotterdam, , Netherlands

Site Status

Countries

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United States Netherlands

Other Identifiers

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03-C-N242

Identifier Type: -

Identifier Source: secondary_id

999903242

Identifier Type: -

Identifier Source: org_study_id

NCT00898196

Identifier Type: -

Identifier Source: nct_alias

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