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NCT00900081 Clinical Trial

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

Cervical Cancer Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT00900081
Other study ID # CDR0000550067
Secondary ID CCCWFU-00A03CCCW
Status Withdrawn
Phase N/A
First received May 9, 2009
Last updated July 28, 2017
Start date May 2003
Est. completion date May 2003

Study information
Verified date October 2015
Source Wake Forest University Health Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date May 2003
Est. primary completion date May 2003
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 120 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Other:
• immunohistochemistry staining method

• laboratory biomarker analysis

• medical chart review

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Wake Forest University Health Sciences National Cancer Institute (NCI)

Outcome
Type Measure Description Time frame Safety issue
Primary Cyclooxygenase-2 (COX-2) levels in cervical intraepithelial neoplasia (CIN) day 1
Primary Correlation of COX-2 levels in CIN with histological diagnosis and parameters of invasion Day 1
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