Ignite Creation Date:
2024-05-05 @ 9:26 PM
Last Modification Date:
2024-10-26 @ 10:04 AM
Study NCT ID:
NCT00880503
Status:
COMPLETED
Last Update Posted:
2019-12-16
First Post:
2009-04-10
Brief Title:
Collection of Tissue Samples for Study of Multidrug Resistance
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Multidrug Resistance Molecular Target Analysis of Human Samples Collected in Clinical Trials Performed Outside of the Intramural National Cancer Institute
Status:
COMPLETED
Status Verified Date:
2018-02-08
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:
Background
Resistance to cancer chemotherapy develops in patients rendering certain treatments ineffective Despite much research the prevailing cause of drug resistance is not known
One mechanism for drug resistance involves a protein called P-glycoprotein or Pgp which reduces the effectiveness of cancer treatments by pumping anti-cancer drugs out of tumor cells where they are supposed to work against the disease
Objectives
To identify and evaluate more thoroughly the roles of Pgp and other substances in mediating drug resistance
Eligibility
Patients enrolled in clinical trials of cancer therapies at the Childrens Hospital of Pittsburgh Cancer Centers of Carolinas Arizona Clinical Research Center University of Copenhagen and Herlev Hospital Copenhagen who have consented to the use of blood tissue or tumor samples for laboratory studies
Design
Blood tumor and tissue samples are collected from participants and sent to the NCI for various laboratory analyses
Resistance to cancer chemotherapy develops in patients rendering certain treatments ineffective Despite much research the prevailing cause of drug resistance is not known
One mechanism for drug resistance involves a protein called P-glycoprotein or Pgp which reduces the effectiveness of cancer treatments by pumping anti-cancer drugs out of tumor cells where they are supposed to work against the disease
Objectives
To identify and evaluate more thoroughly the roles of Pgp and other substances in mediating drug resistance
Eligibility
Patients enrolled in clinical trials of cancer therapies at the Childrens Hospital of Pittsburgh Cancer Centers of Carolinas Arizona Clinical Research Center University of Copenhagen and Herlev Hospital Copenhagen who have consented to the use of blood tissue or tumor samples for laboratory studies
Design
Blood tumor and tissue samples are collected from participants and sent to the NCI for various laboratory analyses
Detailed Description:
Background
Ultimately patients who succumb to cancer do so because of drug resistance Mechanisms of drug resistance have been explored in the laboratory and in clinical samples for some time yet the prevailing cause of drug resistance if indeed there is a single cause is not known One mechanism of drug resistance is multidrug efflux mediated by P-glycoprotein Other mechanisms have been proposed Our laboratory has expertise in the analysis of drug transporter expression and activity in clinical samples
Objectives
To determine expression of P-glycoprotein and other multidrug transporters thought to mediate clinical drug resistance
To evaluate inhibition of P-glycoprotein and other multidrug transporters through assessment of efflux activity in cells obtained from patients enrolled on clinical trials at other institutions
To identify and evaluate mechanisms of drug resistance using molecular assays such as cDNA array real-time PCR analysis and immunohistochemistry
Eligibility
Patients enrolled on clinical trials outside the NCI and giving informed consent to the use of blood tissue or tumor samples for evaluation of mechanisms of drug resistance or evaluation of inhibition of multi-drug efflux
Future collaborations for similar studies will be added via the protocol amendment procedure molecular studies other than ABC transporter assays will be added via the protocol amendment procedure
Design
Human tumor biopsies or blood samples 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 and the samples will be sent to the NCI for immunohistochemical analysis cDNA array PCR analysis or for blood assays for detection of P-glycoprotein inhibition
Ultimately patients who succumb to cancer do so because of drug resistance Mechanisms of drug resistance have been explored in the laboratory and in clinical samples for some time yet the prevailing cause of drug resistance if indeed there is a single cause is not known One mechanism of drug resistance is multidrug efflux mediated by P-glycoprotein Other mechanisms have been proposed Our laboratory has expertise in the analysis of drug transporter expression and activity in clinical samples
Objectives
To determine expression of P-glycoprotein and other multidrug transporters thought to mediate clinical drug resistance
To evaluate inhibition of P-glycoprotein and other multidrug transporters through assessment of efflux activity in cells obtained from patients enrolled on clinical trials at other institutions
To identify and evaluate mechanisms of drug resistance using molecular assays such as cDNA array real-time PCR analysis and immunohistochemistry
Eligibility
Patients enrolled on clinical trials outside the NCI and giving informed consent to the use of blood tissue or tumor samples for evaluation of mechanisms of drug resistance or evaluation of inhibition of multi-drug efflux
Future collaborations for similar studies will be added via the protocol amendment procedure molecular studies other than ABC transporter assays will be added via the protocol amendment procedure
Design
Human tumor biopsies or blood samples 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 and the samples will be sent to the NCI for immunohistochemical analysis cDNA array PCR analysis or for blood assays for detection of P-glycoprotein inhibition
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 |
|---|---|---|---|
| 04-C-N067 | None | None | None |