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

Cervical Cancer Clinical Trial

Official title:

Measurement of Fluorescence EEM of Cervical Intraepithelial Neoplasia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00632190
• Other study ID #: CDR0000581311
• Secondary ID: BCCR-C99-0441C99
• Status: Completed
• Phase: N/A
• First received: March 7, 2008
• Last updated: January 27, 2010
• Start date: January 2000

Study information

• Verified date: January 2009
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1800
• Est. primary completion date: March 2003
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Cervical Cancer
• Cervical Intraepithelial Neoplasia
• Precancerous Condition
• Precancerous Conditions
• Uterine Cervical Neoplasms

Intervention

Other:
• fluorophotometry

Procedure:
• colposcopic biopsy

• colposcopy

• light-scattering spectroscopy

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
British Columbia Cancer Agency	National Cancer Institute (NCI)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurement of reflection and fluorescence spectra in vivo of sites in the human cervix			No
Primary	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			No
Primary	Validation of wavelength selections for the spectroscopy device derived from in vitro measurements			No
Primary	Sensitivity and specificity of this device for the diagnosis of cervical intraepithelial neoplasia			No