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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion 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.

Interventions

  • Other: immunohistochemistry staining method
  • Other: laboratory biomarker analysis
  • Other: medical chart review

Clinical Trial Outcome Measures

Primary Measures

  • Cyclooxygenase-2 (COX-2) levels in cervical intraepithelial neoplasia (CIN)
    • Time Frame: day 1
  • Correlation of COX-2 levels in CIN with histological diagnosis and parameters of invasion
    • Time Frame: Day 1

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 120 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Wake Forest University Health Sciences
  • Collaborator
    • National Cancer Institute (NCI)
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Brigitte E. Miller, MD, Study Chair, Wake Forest University Health Sciences

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