Analyses of Human Samples Collected in Clinical Trials

National Cancer Institute (NCI)

Status: Completed

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

Study type: Observational

Funder types: NIH

Identifiers

NCT00339664

999903242

03-C-N242

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,579 patients

Sex: All

Ages: Under 100 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

2,579 participants in 1 patient group

1/ patients

Description:

Patients on approved clinical trials