Spectroscopy in Diagnosing Dysplasia and Neoplasia in the Cervix in Women Undergoing Colposcopy

British Columbia Cancer Agency1,800 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Purpose

DIAGNOSTIC

Masking

NONE

Conditions

Cervical Cancer Precancerous Condition

Interventions

fluorophotometryOTHER

colposcopic biopsyPROCEDURE

colposcopyPROCEDURE

light-scattering spectroscopyPROCEDURE

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Measurement of reflection and fluorescence spectra in vivo of sites in the human cervix

Refinement of 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

Validation of wavelength selections for the spectroscopy device derived from in vitro measurements

Sensitivity and specificity of this device for the diagnosis of cervical intraepithelial neoplasia

Data from ClinicalTrials.gov

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