Analyses of Human Samples Collected in Clinical Trials

Completed

• Conditions: Neoplasm Metastasis; Leukemia, Lymphoid; Prostate Cancer; Leukemia, Myeloid

• Registration Number: NCT00339664
• Lead Sponsor: National Cancer Institute (NCI)

Brief Summary

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

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 Timeline

• Study Start: 2003-07-02
• Study First Submitted: 2006-06-19
• Study First Submitted QC: 2006-06-19
• Study First Posted: 2006-06-21
• Status Verified: 2020-03
• Primary Completion: 2020-03-17
• Study Completion: 2020-03-26
• Last Update Submitted: 2020-03-27
• Last Update Posted: 2020-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2579

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Drug and/or metabolite concentration	Ongoing	To quantitate drug and/or metabolite concentrations in human blood samples

Secondary Outcome Measures

Name	Time	Method
Pharmacological behavior of agents	Ongoing	To characterize the clinical pharmacological behavior of agents

Trial Locations

Locations (17)

Childrens National Medical Center; 🇺🇸 Washington, District of Columbia, United States

H. Lee Moffitt Cancer Center & Research Institute; 🇺🇸 Tampa, Florida, United States

University of Chicago; 🇺🇸 Chicago, Illinois, United States

Case Western Reserve University; 🇺🇸 Cleveland, Ohio, United States

Mayo Clinic, Rochester; 🇺🇸 Rochester, Minnesota, United States

University of Maryland at Amish Research Clinic, Lancaster; 🇺🇸 Lancaster, Pennsylvania, United States

Abramson Cancer Center, University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

Hollings Cancer Center at Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States

Hillman Cancer Center at University of Pittsburg Cancer Institute; 🇺🇸 Pittsburgh, Pennsylvania, United States

McGuire Veterans Administration Medical Center; 🇺🇸 Richmond, Virginia, United States

Massey Cancer Center, Virginia Commonwealth University; 🇺🇸 Richmond, Virginia, United States

Leiden University Medical Center; 🇳🇱 Leiden, Netherlands

Erasmus Medical Center; 🇳🇱 Rotterdam, Netherlands

University of Maryland, Baltimore; 🇺🇸 Baltimore, Maryland, United States

Johns Hopkins Medical Center; 🇺🇸 Baltimore, Maryland, United States

Sidney Kimmel Comprehensive Cancer Center; 🇺🇸 Baltimore, Maryland, United States

National Institutes of Health Clinical Center, 9000 Rockville Pike; 🇺🇸 Bethesda, Maryland, United States