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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00900081
Recruitment Status : Withdrawn (no accrual, PI left institution)
First Posted : May 12, 2009
Last Update Posted : August 1, 2017
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Brief Summary:

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

Detailed Description:


  • 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
Actual Enrollment : 0 participants
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
Actual Study Start Date : May 2003
Actual Primary Completion Date : May 2003
Actual Study Completion Date : May 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer
U.S. FDA Resources

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with Cervical Intraepithelial Neoplasia


  • 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


  • Not specified


  • Not specified

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00900081

Sponsors and Collaborators
Wake Forest University Health Sciences
National Cancer Institute (NCI)
Study Chair: Brigitte E. Miller, MD Wake Forest University Health Sciences

Responsible Party: Wake Forest University Health Sciences Identifier: NCT00900081     History of Changes
Other Study ID Numbers: CDR0000550067
First Posted: May 12, 2009    Key Record Dates
Last Update Posted: August 1, 2017
Last Verified: October 2015

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Wake Forest University Health Sciences:
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:
Uterine Cervical Neoplasms
Carcinoma in Situ
Cervical Intraepithelial Neoplasia
Precancerous Conditions
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type