Fluorescence and Reflectance Spectroscopy During Colposcopy in Detecting Cervical Intraepithelial Neoplasia and Dysplasia in Healthy Participants With a History of Normal Pap Smears
RATIONALE: New diagnostic procedures such as fluorescence and reflectance spectroscopy (shining light on tissue and measuring patterns of light reflected) may improve the ability to noninvasively detect cervical intraepithelial neoplasia and dysplasia.
PURPOSE: This diagnostic trial is studying how well fluorescence and reflectance spectroscopy during colposcopy work in detecting cervical intraepithelial neoplasia and dysplasia in healthy participants with a history of normal Pap smears.
Procedure: Colposcopic biopsy
Procedure: Light-Scattering Spectroscopy
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Pathological Correlation of Colposcopically Directed Biopsies to Fluorescence EEM of the Normal Human Cervix|
- Fluorescent Measurements of Cervix [ Time Frame: Participation complete after readings of several 2.5 minutes fluorescent measurements and biopsies taken during colposcopy. ] [ Designated as safety issue: No ]Two fluorescent measurements of cervix, approximately 2.5 minutes each: 1)colposcopically normal columnar site, and 2) a colposcopically normal squamous site.
|Study Start Date:||April 1998|
|Study Completion Date:||February 2009|
|Primary Completion Date:||July 2007 (Final data collection date for primary outcome measure)|
|Experimental: Fluorescence Spectroscopy||
Procedure: Colposcopic biopsy
Two small samples of cervical tissue (biopsy) removed from 2 sites as spectroscopy readings.
Other Name: biopsyProcedure: Light-Scattering Spectroscopy
Spectroscopy readings taken in 2 regions of cervix.
- Identify potential improvements in noninvasive methods of diagnosing dysplasia and neoplasia of the cervix using fluorescence and reflectance spectroscopy in healthy participants with a history of normal pap smears.
- Determine the reflection and fluorescence spectra of in vivo samples of the normal human cervix.
- Refine the detection of cervical lesions by fluorescence spectroscopy in these participants using improved classification of normal columnar tissue and non-neoplastic tissue with inflammation.
- Determine and validate the wavelength selections for spectroscopic diagnosis derived from in vitro measurements from these participants.
- Compare specific tissue sections from these participants with their excitation-emission matrices in order to identify the cell types contributing to the signal.
OUTLINE: Participants undergo placement of a fiber optic probe on one normal columnar cell site and one normal squamous cell site of the cervix during colposcopy*. The probe delivers laser light at a specific excitation wavelength and collects fluorescence from the entire emission wavelength range from the mucosa. Participants undergo biopsies of both sites.
NOTE: *The columnar epithelium will not be colposcopically visible in all patients, in which case 2 normal squamous sites will be measured
PROJECTED ACCRUAL: A total of 1,000 participants will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00084903
|United States, Texas|
|M. D. Anderson Cancer Center at University of Texas|
|Houston, Texas, United States, 77030-4009|
|Canada, British Columbia|
|British Columbia Cancer Agency - Vancouver Cancer Centre|
|Vancouver, British Columbia, Canada, V5Z 4E6|
|Study Chair:||Helen Rhodes, MD||M.D. Anderson Cancer Center|