Analyses of Human Samples Collected in Clinical Trials

National Cancer Institute (NCI)2,579 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

2,579

Conditions

Leukemia, Myeloid Neoplasm Metastasis Leukemia, Lymphoid Prostate Cancer

Eligibility

Sex: ALLMax age: 100 Years

Medical Language ↔ Plain English

* 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 (17)

Childrens National Medical Center

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

H. Lee Moffitt Cancer Center & Research Institute

Outcomes

Primary Outcomes

Drug and/or metabolite concentration

To quantitate drug and/or metabolite concentrations in human blood samples

Time frame: Ongoing

Secondary Outcomes

Pharmacological behavior of agents

To characterize the clinical pharmacological behavior of agents

Time frame: Ongoing

Data from ClinicalTrials.gov

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