Analyses of Human Samples Collected in Clinical Trials

Prostate Cancer Clinical Trial

Official title:

Pharmacological Analysis of Human Samples Collected in Clinical Trials Performed Outside of the Intramural National Cancer Institute

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00339664
• Other study ID #: 999903242
• Secondary ID: 03-C-N242
• Status: Completed
• Start date: July 2, 2003
• Est. completion date: March 26, 2020

Study information

• Verified date: March 2020
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00898196

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2579
• Est. completion date: March 26, 2020
• Est. primary completion date: March 17, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 100 Years

Eligibility

• 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.

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Lymphoid
• Leukemia, Myeloid
• Neoplasm Metastasis
• Prostate Cancer

Locations

Country	Name	City	State
Netherlands	Leiden University Medical Center	Leiden
Netherlands	Erasmus Medical Center	Rotterdam
United States	Johns Hopkins Medical Center	Baltimore	Maryland
United States	Sidney Kimmel Comprehensive Cancer Center	Baltimore	Maryland
United States	University of Maryland, Baltimore	Baltimore	Maryland
United States	National Institutes of Health Clinical Center, 9000 Rockville Pike	Bethesda	Maryland
United States	Hollings Cancer Center at Medical University of South Carolina	Charleston	South Carolina
United States	University of Chicago	Chicago	Illinois
United States	Case Western Reserve University	Cleveland	Ohio
United States	University of Maryland at Amish Research Clinic, Lancaster	Lancaster	Pennsylvania
United States	Abramson Cancer Center, University of Pennsylvania	Philadelphia	Pennsylvania
United States	Hillman Cancer Center at University of Pittsburg Cancer Institute	Pittsburgh	Pennsylvania
United States	Massey Cancer Center, Virginia Commonwealth University	Richmond	Virginia
United States	McGuire Veterans Administration Medical Center	Richmond	Virginia
United States	Mayo Clinic, Rochester	Rochester	Minnesota
United States	H. Lee Moffitt Cancer Center & Research Institute	Tampa	Florida
United States	Childrens National Medical Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Drug and/or metabolite concentration	To quantitate drug and/or metabolite concentrations in human blood samples	Ongoing
Secondary	Pharmacological behavior of agents	To characterize the clinical pharmacological behavior of agents	Ongoing