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This study has been withdrawn prior to enrollment.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:

National Cancer Institute (NCI)

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

History of Changes

Tracking Information

First Received Date ^ICMJE

May 9, 2009

Last Updated Date

June 27, 2012

Start Date ^ICMJE

May 2003

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Cyclooxygenase-2 (COX-2) levels in cervical intraepithelial neoplasia (CIN) [ Designated as safety issue: No ]
Correlation of COX-2 levels in CIN with histological diagnosis and parameters of invasion [ Designated as safety issue: No ]

Change History

Complete list of historical versions of study NCT00900081 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

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 ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

patients with Cervical Intraepithelial Neoplasia

Condition ^ICMJE

Cervical Cancer
Precancerous Condition

Intervention ^ICMJE

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

Study Group/Cohort (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Withdrawn

Enrollment ^ICMJE

Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Female

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT00900081

Other Study ID Numbers ^ICMJE

CDR0000550067, CCCWFU-00A03, CCCWFU-BG01-137

Has Data Monitoring Committee

Responsible Party

Comprehensive Cancer Center of Wake Forest University

Study Sponsor ^ICMJE

Comprehensive Cancer Center of Wake Forest University

Collaborators ^ICMJE

National Cancer Institute (NCI)

Investigators ^ICMJE

Study Chair:

Brigitte E. Miller, MD

Comprehensive Cancer Center of Wake Forest University

Information Provided By

Comprehensive Cancer Center of Wake Forest University

Verification Date

June 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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