Spectroscopy in Diagnosing Dysplasia and Neoplasia in the Cervix in Women Undergoing Colposcopy
Primary Purpose
Cervical Cancer, Precancerous Condition
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
fluorophotometry
colposcopic biopsy
colposcopy
light-scattering spectroscopy
Sponsored by
About this trial
This is an interventional diagnostic trial for Cervical Cancer focused on measuring cervical cancer, cervical intraepithelial neoplasia grade 1, cervical intraepithelial neoplasia grade 2, cervical intraepithelial neoplasia grade 3
Eligibility 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
Sites / Locations
Outcomes
Primary Outcome Measures
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 Outcome Measures
Full Information
NCT ID
NCT00632190
First Posted
March 7, 2008
Last Updated
January 27, 2010
Sponsor
British Columbia Cancer Agency
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT00632190
Brief Title
Spectroscopy in Diagnosing Dysplasia and Neoplasia in the Cervix in Women Undergoing Colposcopy
Official Title
Measurement of Fluorescence EEM of Cervical Intraepithelial Neoplasia
Study Type
Interventional
2. Study Status
Record Verification Date
January 2009
Overall Recruitment Status
Completed
Study Start Date
January 2000 (undefined)
Primary Completion Date
March 2003 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
British Columbia Cancer Agency
Collaborators
National Cancer Institute (NCI)
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer, Precancerous Condition
Keywords
cervical cancer, cervical intraepithelial neoplasia grade 1, cervical intraepithelial neoplasia grade 2, cervical intraepithelial neoplasia grade 3
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Masking
None (Open Label)
Enrollment
1800 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Other
Intervention Name(s)
fluorophotometry
Intervention Type
Procedure
Intervention Name(s)
colposcopic biopsy
Intervention Type
Procedure
Intervention Name(s)
colposcopy
Intervention Type
Procedure
Intervention Name(s)
light-scattering spectroscopy
Primary Outcome Measure Information:
Title
Measurement of reflection and fluorescence spectra in vivo of sites in the human cervix
Title
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
Title
Validation of wavelength selections for the spectroscopy device derived from in vitro measurements
Title
Sensitivity and specificity of this device for the diagnosis of cervical intraepithelial neoplasia
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sylvia Lam
Organizational Affiliation
British Columbia Cancer Agency
12. IPD Sharing Statement
Learn more about this trial
Spectroscopy in Diagnosing Dysplasia and Neoplasia in the Cervix in Women Undergoing Colposcopy
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