Analyses of Human Samples Collected in Clinical Trials

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Status: Enrolling by Invitation

Description

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.

Eligibility Criteria

Inclusion Criteria

  • - 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.

Locations & Contacts

Maryland

Bethesda
National Institutes of Health Clinical Center
Status: Enrolling by invitation
Contact: National Cancer Institute Referral Office
Phone: 888-624-1937

Trial Objectives and Outline

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.

Trial Phase & Type

Trial Phase

No phase specified

Trial Type

Not provided by clinicaltrials.gov

Lead Organization

Lead Organization
National Cancer Institute

Principal Investigator
William Douglas Figg

Trial IDs

Primary ID 999903242
Secondary IDs 03-C-N242, NCI-2018-02190, 03-C-N242, NCI-2013-02044
Clinicaltrials.gov ID NCT00339664