Cervical Cancer Clinical Trial
Official title:
Measurement of Fluorescence EEM of Cervical Intraepithelial Neoplasia
RATIONALE: New diagnostic procedures, such as spectroscopy, may be a less invasive way to
check for dysplasia and neoplasia in the cervix. Spectroscopy may also used as a screening
test to help doctors find cervical cancer sooner, when it may be easier to treat.
PURPOSE: This clinical trial is studying how well spectroscopy works in diagnosing dysplasia
and neoplasia in the cervix in women undergoing colposcopy or Pap testing.
OBJECTIVES:
- To identify potential improvements for a noninvasive method of diagnosing dysplasia and
neoplasia in the cervix using fluorescence and reflectance spectroscopy.
- To measure the reflection and fluorescence spectra in vivo of sites in the human
cervix.
- To further refine fluorescence spectroscopy for detection of cervical lesions via
better classification of normal columnar tissue and non-neoplastic tissue with
inflammation, and low- and high-grade squamous intraepithelial lesions.
- Evaluate and validate the wavelength selections for the spectroscopy device derived
from in vitro measurements.
- Determine the sensitivity and specificity of this device for the diagnosis of cervical
intraepithelial neoplasia.
OUTLINE: This is a multicenter study. Patients are stratified according to menopausal status
and current treatment (premenopausal not on oral contraceptive pills [OCP] vs premenopausal
on OCP vs postmenopausal not on hormone replacement therapy [HRT] vs postmenopausal on HRT).
- Diagnostic study: As part of routine colposcopic evaluation, patients undergo placement
of the probe on 1 to 4 sites in the cervix for 2-5 minutes. Up to two colposcopically
abnormal sites and two normal sites are biopsied. Blood is drawn for hormone levels.
Fluorescence excitation and emission matrix (EEM) data and reflectance spectroscopic
information is acquired from patients with an abnormal Papanicolaou smear.
- Screening study: Fluorescence EEM and reflectance spectroscopic information is acquired
from patients with a history of normal Papanicolaou smears.
PROJECTED ACCRUAL: A total of 800 patients with abnormal Papanicolaou smears and 1000
subjects with normal Papanicolaou smears are accrued for this study.
;
Masking: Open Label, Primary Purpose: Diagnostic
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