NCT00880503

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 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. ...

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
325

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2003

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 19, 2003

Completed
5.3 years until next milestone

First Submitted

Initial submission to the registry

April 10, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 13, 2009

Completed
8.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 8, 2018

Completed
Last Updated

December 16, 2019

Status Verified

February 8, 2018

First QC Date

April 10, 2009

Last Update Submit

December 13, 2019

Conditions

Keywords

Multidrug Resistance Molecular Target Analysis

Outcome Measures

Primary Outcomes (1)

  • Expression of MDR1/P-glycoprotein and related drug resistance proteins

    Upon receipt and processing of specimen

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • None anticipated at this time.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Childrens Hospital, Pittsburgh

Pittsburgh, Pennsylvania, 15213-2583, United States

Location

Related Publications (3)

  • Gottesman MM, Fojo T, Bates SE. Multidrug resistance in cancer: role of ATP-dependent transporters. Nat Rev Cancer. 2002 Jan;2(1):48-58. doi: 10.1038/nrc706.

    PMID: 11902585BACKGROUND
  • Baer MR, George SL, Dodge RK, O'Loughlin KL, Minderman H, Caligiuri MA, Anastasi J, Powell BL, Kolitz JE, Schiffer CA, Bloomfield CD, Larson RA. Phase 3 study of the multidrug resistance modulator PSC-833 in previously untreated patients 60 years of age and older with acute myeloid leukemia: Cancer and Leukemia Group B Study 9720. Blood. 2002 Aug 15;100(4):1224-32.

    PMID: 12149202BACKGROUND
  • Robey R, Bakke S, Stein W, Meadows B, Litman T, Patil S, Smith T, Fojo T, Bates S. Efflux of rhodamine from CD56+ cells as a surrogate marker for reversal of P-glycoprotein-mediated drug efflux by PSC 833. Blood. 1999 Jan 1;93(1):306-14.

    PMID: 9864175BACKGROUND

MeSH Terms

Conditions

Breast NeoplasmsCarcinoma, Medullary

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesCarcinoma, NeuroendocrineNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms, Ductal, Lobular, and MedullaryNeoplasms, Nerve Tissue

Study Officials

  • William D Figg, Pharm.D.

    National Cancer Institute (NCI)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 10, 2009

First Posted

April 13, 2009

Study Start

December 19, 2003

Study Completion

February 8, 2018

Last Updated

December 16, 2019

Record last verified: 2018-02-08

Locations