Digital Colposcopy in Finding Cervical Intraepithelial Neoplasia - Full Text View

Sponsors and Collaborators:	British Columbia Cancer Agency National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00602368

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.

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

MedlinePlus related topics: Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic
Official Title:	Measurement of Digital Colposcopy for Fluorescence Spectroscopy of Cervical Intraepithelial Neoplasia: A Pilot Study

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 digital colposcopy and fluorescence spectroscopic imaging [ Designated as safety issue: No ]
Measurement of fluorescence and reflectance images of the human cervix in vivo using digital colposcopy [ Designated as safety issue: No ]
Effect of acetic acid on the image contrast [ Designated as safety issue: No ]
Comparison of device performance with colposcopic impression and histopathologic interpretation of tissue removed by standard loop electrosurgical excision procedure (LEEP) [ Designated as safety issue: No ]

Estimated Enrollment:	114
Study Start Date:	October 2004
Estimated Primary Completion Date:	April 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 digital colposcopy and fluorescence spectroscopic imaging.
To measure fluorescence and reflectance images of the human cervix in vivo using digital colposcopy.
To evaluate the effect of acetic acid on the image contrast obtained.
To compare the device performance with colposcopic impression and histopathologic interpretation of tissue removed by standard loop electrosurgical excision procedure (LEEP).

OUTLINE: This is a multicenter study.

Participants undergo routine colposcopy as part of their regular colposcopic evaluation. The digital colposcope is used to take fluorescence and reflectance images of the vagina and cervix. Participants also undergo loop electrosurgical excision procedure (LEEP). The digital colposcopic images are compared with tissue removed during LEEP. Additional surrogate biomarkers under development are also measured using tissue samples removed during LEEP, such as quantitative histopathology measurements, DNA tests for the copy number changes, and tests for the incorporation of viral HPV DNA.

Eligibility

Ages Eligible for Study:	19 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 colposcopy and loop electrosurgical excision procedure (LEEP):
- B.C. Cancer Agency/VGH
- U.T. M.D. Anderson Cancer Center
- U.T. Health Science Center
- Lyndon B. Johnson General Hospital
- University College Hospital, Ibadan, Oyo State, Nigeria, Africa colposcopy clinics

PATIENT CHARACTERISTICS:

Not pregnant
Negative pregnancy test

PRIOR CONCURRENT THERAPY:

See Disease Characteristics

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00602368

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

British Columbia Cancer Agency

National Cancer Institute (NCI)

Investigators

Investigator:

Sylvia Au

British Columbia Cancer Agency

More Information

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

Study ID Numbers:	CDR0000581286, BCCR-H03-61235, H03-61235
Study First Received:	January 25, 2008
Last Updated:	December 2, 2008
ClinicalTrials.gov Identifier:	NCT00602368
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:

Signs and Symptoms
Precancerous Conditions
Cervical intraepithelial neoplasia
Carcinoma in Situ

Neoplasms, Glandular and Epithelial
Carcinoma
Cervical Intraepithelial Neoplasia

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on January 14, 2009