Trial Information

Pathological Correlation of Colposcopically Directed Biopsies to Fluorescence EEM of the Normal Human Cervix

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.