Cervical Cancer Clinical Trial
Official title:
Pathological Correlation of Colposcopically Directed Biopsies to Fluorescence EEM of the Normal Human Cervix
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.
OBJECTIVES:
- 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.
;
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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