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Assessment of EGFR Genomic Alterations as Prognostic Markers in Cervical Cancer

This study has been completed.
Sponsor:
Information provided by:
University of New Mexico
ClinicalTrials.gov Identifier:
NCT00298064
First received: February 28, 2006
Last updated: January 6, 2010
Last verified: November 2009
History of Changes
  Purpose

The Tissue Repository will search for cases, pull slides, Paraffin-embedded tissue (PET) blocks.


Condition Intervention
Cervical Cancer
Cervix
 Genetic: Tissue Repository

Study Type: Interventional
Official Title: Assessment of EGFR Genomic Alterations as Prognostic Markers in Cervical Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of New Mexico:

Enrollment: 300
Study Start Date: December 2005
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Detailed Description:

This study is done to gather preliminary data for determining the best way to test EGFR expression in patients with cervical cancer who will receive treatment with EGFR inhibitors in the future.

This study is designed to obtain preliminary data of genomic and phenotypic alterations of the EGFR pathway in high grade cervical intraepithelial lesions (HG-SIL) and invasive cervical cancers (CC) to be used later for therapeutic guidance and to evaluate genomic (over-expression, amplification, point mutations, etc.) and phenotypic alterations of other transduction pathways interacting with the EGFR pathway.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Samples from patients diagnosed with HG-SIL (n=300) and CC (n=300) with a follow-up of at least 24 months, existing at the Department of Pathology will be retrieved by the Tissue Repository, de-identified them and provided with code numbers that will not be linked to patient's data.

Exclusion Criteria:

  • None Specified.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00298064

Locations
United States, New Mexico
University of New Mexico
Albuquerque, New Mexico, United States, 87131
Sponsors and Collaborators
University of New Mexico
Investigators
Principal Investigator: Claire Verschraegen, MD University of New Mexico
  More Information

No publications provided

Responsible Party: Claire Verschraegen, MD; Principal Investigator, University of New Mexico
ClinicalTrials.gov Identifier: NCT00298064     History of Changes
Other Study ID Numbers: INST 0548C
Study First Received: February 28, 2006
Last Updated: January 6, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of New Mexico:
Cervical cancer
EGFR
cervical
genomic
DNA
 markers
prognostic
gene
epidermal growth factor

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
 Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on May 23, 2013