Collection of Tissue Samples for Study of Multidrug Resistance

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )
ClinicalTrials.gov Identifier:
NCT00880503
First received: April 10, 2009
Last updated: April 11, 2015
Last verified: March 2015
  Purpose

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 Children's 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.


Condition
Breast Carcinoma
Breast Cancer
Medullary Thyroid Carcinoma

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Multidrug Resistance Molecular Target Analysis of Human Samples Collected in Clinical Trials Performed Outside of the Intramural National Cancer Institute

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • Expression of MDR1/P-glycoprotein and related drug resistance proteins [ Time Frame: Upon receipt and processing of specimen ] [ Designated as safety issue: No ]

Estimated Enrollment: 9999
Study Start Date: December 2003
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:

Any patients entered on approved trials of cancer therapeutics at Children's Hospital of Pittsburgh, Herlev Hospital, and the University of Copenhagen outside of the intramural NCI are eligible for inclusion, provided that they have consented to tumor studies in the original consent forms.

EXCLUSION CRITERIA:

None anticipated at this time.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00880503

Locations
United States, Missouri
Washington University, St. Louis
St. Louis, Missouri, United States, 63110
United States, Pennsylvania
Childrens Hospital, Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213-2583
Sponsors and Collaborators
Investigators
Principal Investigator: Susan E Bates, M.D. National Cancer Institute (NCI)
  More Information

Publications:
Responsible Party: National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )
ClinicalTrials.gov Identifier: NCT00880503     History of Changes
Obsolete Identifiers: NCT00898001
Other Study ID Numbers: 999904067, 04-C-N067
Study First Received: April 10, 2009
Last Updated: April 11, 2015
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Multidrug Resistance Molecular Target Analysis

Additional relevant MeSH terms:
Breast Neoplasms
Carcinoma
Thyroid Neoplasms
Breast Diseases
Endocrine Gland Neoplasms
Endocrine System Diseases
Head and Neck Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Skin Diseases
Thyroid Diseases

ClinicalTrials.gov processed this record on July 26, 2015