Ignite Creation Date:
2024-05-05 @ 4:53 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00339664
Status:
COMPLETED
Last Update Posted:
2020-03-30
First Post:
2006-06-19
Brief Title:
Analyses of Human Samples Collected in Clinical Trials
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Pharmacological Analysis of Human Samples Collected in Clinical Trials Performed Outside of the Intramural National Cancer Institute
Status:
COMPLETED
Status Verified Date:
2020-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Cancer patients in clinical trials donate various human samples eg 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
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 eg serum plasma whole blood erythrocytes urine feces bile andor 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 andor 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 03-C-N242 | None | None | None |