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

July 28, 2017 updated by: Wake Forest University Health Sciences

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Observational

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

patients with Cervical Intraepithelial Neoplasia

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wake Forest University Health Sciences

Collaborators

National Cancer Institute (NCI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2003

Primary Completion (Actual)

May 1, 2003

Study Completion (Actual)

May 1, 2003

Study Registration Dates

First Submitted

May 9, 2009

First Submitted That Met QC Criteria

May 9, 2009

First Posted (Estimate)

May 12, 2009

Study Record Updates

Last Update Posted (Actual)

August 1, 2017

Last Update Submitted That Met QC Criteria

July 28, 2017

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000550067
  • CCCWFU-00A03
  • CCCWFU-BG01-137

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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