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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
British Columbia Cancer Agency
About
Eligibility
Locations
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

    First Posted
    March 7, 2008
    Last Updated
    January 27, 2010
    Sponsor
    British Columbia Cancer Agency
    Collaborators
    National Cancer Institute (NCI)
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    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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