Cyclooxygenase-2 Expression in Tissue Samples From Patients With a Normal Cervix, Cervical Intraepithelial Neoplasia, or Early Invasive Cervical Cancer

This study has been withdrawn prior to enrollment.
(no accrual, PI left institution)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov Identifier:
NCT00900081
First received: May 9, 2009
Last updated: June 27, 2012
Last verified: June 2012
  Purpose

RATIONALE: Studying samples of tissue from patients with or without cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer.

PURPOSE: This laboratory study is looking at cyclooxygenase-2 expression in tissue samples from patients with a normal cervix, cervical intraepithelial neoplasia, or early invasive cervical cancer.


Condition Intervention
Cervical Cancer
Precancerous Condition
Other: immunohistochemistry staining method
Other: laboratory biomarker analysis
Other: medical chart review

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Cyclooxygenase-2 Expression in Normal Cervix, Cervical Intraepithelial Neoplasia and Early Invasive Squamous Cell Carcinoma With Correlation to Parameters of Invasion and Angiogenesis

Resource links provided by NLM:


Further study details as provided by Comprehensive Cancer Center of Wake Forest University:

Primary Outcome Measures:
  • Cyclooxygenase-2 (COX-2) levels in cervical intraepithelial neoplasia (CIN) [ Time Frame: day 1 ] [ Designated as safety issue: No ]
  • Correlation of COX-2 levels in CIN with histological diagnosis and parameters of invasion [ Time Frame: Day 1 ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: May 2003
Detailed Description:

OBJECTIVES:

  • Determine cyclooxygenase-2 (COX-2) levels in biopsy or surgical specimens from patients with normal cervical epithelium, cervical intraepithelial neoplasia, or microinvasive squamous cell carcinoma of the cervix.
  • Correlate COX-2 levels with histological diagnosis and parameters of invasion (i.e., matrix metalloproteinase, microvessel count, and VEGF).

OUTLINE: Paraffin-embedded tissue samples are analyzed by immunohistochemistry for evaluation of cyclooxygenase-2 levels, microvessel count, and matrix metalloproteinase and VEGF expression.

Medical data for study analysis is obtained by retrospective review of patient charts.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

patients with Cervical Intraepithelial Neoplasia

Criteria

DISEASE CHARACTERISTICS:

  • Meets 1 of the following criteria:

    • Underwent hysterectomy with removal of a normal cervix for diagnosis unrelated to cancer or cervical dysplasia
    • Underwent cervical biopsy or removal of cervical tissue and diagnosed with cervical intraepithelial neoplasia (CIN) grades 1-3
    • Underwent cervical biopsy and diagnosed with microinvasive squamous cell carcinoma of the cervix
  • Paraffin-embedded tissue samples of normal cervical epithelium, CIN, or microinvasive squamous cell carcinoma of the cervix must be available for examination

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • Not specified
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00900081

Sponsors and Collaborators
Comprehensive Cancer Center of Wake Forest University
Investigators
Study Chair: Brigitte E. Miller, MD Comprehensive Cancer Center of Wake Forest University
  More Information

No publications provided

Responsible Party: Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov Identifier: NCT00900081     History of Changes
Other Study ID Numbers: CDR0000550067, CCCWFU-00A03, CCCWFU-BG01-137
Study First Received: May 9, 2009
Last Updated: June 27, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Comprehensive Cancer Center of Wake Forest University:
cervical squamous cell carcinoma
stage IA cervical cancer
stage 0 cervical cancer
cervical intraepithelial neoplasia grade 1
cervical intraepithelial neoplasia grade 2
cervical intraepithelial neoplasia grade 3

Additional relevant MeSH terms:
Carcinoma in Situ
Carcinoma, Squamous Cell
Cervical Intraepithelial Neoplasia
Neoplasms
Precancerous Conditions
Uterine Cervical Neoplasms
Carcinoma
Genital Diseases, Female
Genital Neoplasms, Female
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Neoplasms, Squamous Cell
Urogenital Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Uterine Neoplasms

ClinicalTrials.gov processed this record on October 23, 2014