Spectroscopy in Diagnosing Dysplasia and Neoplasia in the Cervix in Women Undergoing Colposcopy
Spectroscopy in Diagnosing Dysplasia and Neoplasia in the Cervix in Women Undergoing Colposcopy
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.
DISEASE CHARACTERISTICS:

 -  Referred to the Colposcopy clinic at Vancouver General Hospital, the MD Anderson
 Cancer Center, or the University of Texas at Austin

 -  Abnormal or normal Papanicolaou smear

 -  Hormone receptor status not specified

 PATIENT CHARACTERISTICS:

 -  Pre or post-menopausal

 -  Not pregnant

 PRIOR CONCURRENT THERAPY:

 -  Not specified