Analyses of Human Samples Collected in Clinical Trials

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00339664

Enrollment

2579

Registered

2006-06-21

Start date

2003-07-02

Completion date

2020-03-26

Last updated

2020-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Pharmacokinetics, Quantify, HPLC, LC/MS, Pharmacodynamics

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

No minimum to 100 Years

Healthy volunteers

Inclusion 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.

Design outcomes

Primary

Measure	Time frame	Description
Drug and/or metabolite concentration	Ongoing	To quantitate drug and/or metabolite concentrations in human blood samples

Secondary

Measure	Time frame	Description
Pharmacological behavior of agents	Ongoing	To characterize the clinical pharmacological behavior of agents

Countries

Netherlands, United States

Outcome results