Analyses of Human Samples Collected in Clinical Trials

Sponsor

National Cancer Institute (NCI) (NIH)

Overall Status

Completed

CT.gov ID

NCT00339664

Collaborator

(none)

2,579

Enrollment

Locations

200.8

Actual Duration (Months)

151.7

Patients Per Site

0.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Leukemia, Myeloid Neoplasm Metastasis Leukemia, Lymphoid Prostate Cancer

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 Design

Study Type:

Observational

Actual Enrollment :

2579 participants

Observational Model:

Case-Only

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Jul 2, 2003

Actual Primary Completion Date :

Mar 17, 2020

Actual Study Completion Date :

Mar 26, 2020

Arms and Interventions

Arm	Intervention/Treatment
1/ patients Patients on approved clinical trials

Outcome Measures

Primary Outcome Measures

Drug and/or metabolite concentration [Ongoing]
To quantitate drug and/or metabolite concentrations in human blood samples

Secondary Outcome Measures

Pharmacological behavior of agents [Ongoing]
To characterize the clinical pharmacological behavior of agents

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Childrens National Medical Center	Washington	District of Columbia	United States
2	H. Lee Moffitt Cancer Center & Research Institute	Tampa	Florida	United States	33612
3	University of Chicago	Chicago	Illinois	United States	60637
4	University of Maryland, Baltimore	Baltimore	Maryland	United States	21201-1595
5	Johns Hopkins Medical Center	Baltimore	Maryland	United States	21231
6	Sidney Kimmel Comprehensive Cancer Center	Baltimore	Maryland	United States	21231
7	National Institutes of Health Clinical Center, 9000 Rockville Pike	Bethesda	Maryland	United States	20892
8	Mayo Clinic, Rochester	Rochester	Minnesota	United States	55905
9	Case Western Reserve University	Cleveland	Ohio	United States	44106-2602
10	University of Maryland at Amish Research Clinic, Lancaster	Lancaster	Pennsylvania	United States
11	Abramson Cancer Center, University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104
12	Hillman Cancer Center at University of Pittsburg Cancer Institute	Pittsburgh	Pennsylvania	United States	15261
13	Hollings Cancer Center at Medical University of South Carolina	Charleston	South Carolina	United States	29425
14	McGuire Veterans Administration Medical Center	Richmond	Virginia	United States	23249
15	Massey Cancer Center, Virginia Commonwealth University	Richmond	Virginia	United States	23298
16	Leiden University Medical Center	Leiden		Netherlands
17	Erasmus Medical Center	Rotterdam		Netherlands