Measurement of Fluorescence EEM of Cervical Intraepithelial Neoplasia
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 1,800
- Primary Endpoint
- Measurement of reflection and fluorescence spectra in vivo of sites in the human cervix
Study Overview
Brief Summary
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.
Detailed Description
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 Design
- Study Type
- Interventional
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
Exclusion Criteria
- Not provided
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
Secondary Outcomes
No secondary outcomes reported