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Assessment of EGFR Genomic Alterations as Prognostic Markers in Cervical Cancer

Primary Purpose

Cervical Cancer, Cervix

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tissue Repository
Sponsored by
University of New Mexico
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional trial for Cervical Cancer focused on measuring Cervical cancer, EGFR, cervical, genomic, DNA, markers, prognostic, gene, epidermal growth factor

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • University of New Mexico

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
February 28, 2006
Last Updated
June 30, 2023
Sponsor
University of New Mexico
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1. Study Identification

Unique Protocol Identification Number
NCT00298064
Brief Title
Assessment of EGFR Genomic Alterations as Prognostic Markers in Cervical Cancer
Official Title
Assessment of EGFR Genomic Alterations as Prognostic Markers in Cervical Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Withdrawn
Study Start Date
December 2005 (Actual)
Primary Completion Date
December 2005 (Actual)
Study Completion Date
December 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of New Mexico

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer, Cervix
Keywords
Cervical cancer, EGFR, cervical, genomic, DNA, markers, prognostic, gene, epidermal growth factor

7. Study Design

Study Phase
Not Applicable
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Genetic
Intervention Name(s)
Tissue Repository

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claire Verschraegen, MD
Organizational Affiliation
University of New Mexico
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of New Mexico
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Assessment of EGFR Genomic Alterations as Prognostic Markers in Cervical Cancer

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