Digital Colposcopy in Finding Cervical Intraepithelial Neoplasia in Patients With An Abnormal Pap Smear - Full Text View

Purpose

RATIONALE: Diagnostic procedures, such as digital colposcopy, may help doctors find and diagnose cervical intraepithelial neoplasia.

PURPOSE: This clinical trial is studying digital colposcopy to see how well it works in finding cervical intraepithelial neoplasia in patients with an abnormal Pap smear.

Condition	Intervention
Cervical Cancer Precancerous/Nonmalignant Condition	Procedure: colposcopic biopsy Procedure: colposcopy Procedure: light-scattering spectroscopy Procedure: loop electrosurgical excision procedure

MedlinePlus related topics:

Cancer Cervical Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic

Official Title:	A Pilot Study: Measurement of Digital Colposcopy for Fluorescence Spectroscopy of Cervical Intraepithelial Neoplasia Using a Second Generation Device

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Identification of potential improvements for a noninvasive method of diagnosing cervical dysplasia and neoplasia using the Multispectral Digital Colposcope (MDC) [ Designated as safety issue: No ]
Measurement of MDC images in vivo of the cervix [ Designated as safety issue: No ]
Effect of the fading of acetic acid in the image contrast obtained over time and its prediction of the grade of intraepithelial neoplasia [ Designated as safety issue: No ]
Mapping of the cervix and comparison of map with routine colposcopic images as well as with those from the MDC [ Designated as safety issue: No ]
Comparison of MDC performance with colposcopy and pathologic analysis of tissue removed after colposcopy in the form of the loop electrosurgical excision procedure (LEEP) [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	January 2008
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

To identify potential improvements for a noninvasive method of diagnosing cervical dysplasia and neoplasia using the Multispectral Digital Colposcope (MDC), a device that uses fluorescence and reflectance spectroscopy to compare images with histopathologic mapping of the cervical epithelium.
To measure MDC images in vivo of the cervix using a modified device that makes measurements in seconds rather than over 2 minutes before and after acetic acid.
To evaluate, preliminarily, the effect of the fading of acetic acid in the image contrast obtained over time to see if this fading can predict the grade of intraepithelial neoplasia.
To evaluate mapping of the cervix so that software can reconstruct the cervical epithelial map to compare the map with routine colposcopic images as well as with those from the MDC.
To compare, preliminarily, MDC performance with colposcopy and pathologic analysis of tissue removed after colposcopy in the form of the loop electrosurgical excision procedure (LEEP).

OUTLINE: This is a multicenter study.

Patients undergo routine colposcopy as part of their regular colposcopic evaluation. The digital colposcope is used to take images of the vagina and cervix, pre- and post-acetic acid, using white, green, and blue light. Colposcopically abnormal areas are biopsied; a normal area may also be biopsied. Patients undergoing loop electrosurgical excision procedure (LEEP) may undergo one additional biopsy of a colposcopically normal site.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Has been referred to any of the following medical centers or clinics for evaluation of an abnormal Papanicolaou smear:
- U.T. M.D. Anderson Cancer Center
- U.T. Health Science Center-Houston
- Lyndon B. Johnson General Hospital
- British Columbia Cancer Agency
- University College Hospital, Ibadan, Oyo State, Nigeria, Africa colposcopy clinics

PATIENT CHARACTERISTICS:

Not pregnant
Negative pregnancy test

PRIOR CONCURRENT THERAPY:

Not specified

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00610662

Locations


United States, Texas
	M. D. Anderson Cancer Center at University of Texas	Recruiting
	Houston, Texas, United States, 77030-4009
	Contact: Clinical Trials Office - M. D. Anderson Cancer Center at the U 713-792-3245

Canada, British Columbia
	BC Cancer Research Centre	Recruiting
	Vancouver, British Columbia, Canada, V5Z 1L3
	Contact: Sylvia Au 604-675-8093

Sponsors and Collaborators

BC Cancer Research Centre

National Cancer Institute (NCI)

Investigators


Investigator:	Sylvia Au	BC Cancer Research Centre

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000581295, BCCR-H07-01272
First Received:	February 7, 2008
Last Updated:	September 22, 2008
ClinicalTrials.gov Identifier:	NCT00610662
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

cervical cancer

cervical intraepithelial neoplasia grade 1

cervical intraepithelial neoplasia grade 2

cervical intraepithelial neoplasia grade 3

Study placed in the following topic categories:

Precancerous Conditions

Genital Neoplasms, Female

Uterine Diseases

Urogenital Neoplasms

Cervical Intraepithelial Neoplasia

Carcinoma

Uterine Cervical Neoplasms

Genital Diseases, Female

Signs and Symptoms

Uterine Cervical Diseases

Cervical intraepithelial neoplasia

Carcinoma in Situ

Uterine Neoplasms

Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Histologic Type

Neoplasms by Site

ClinicalTrials.gov processed this record on October 15, 2008

Sponsors and Collaborators:	BC Cancer Research Centre National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00610662