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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00632190
First received: March 7, 2008
Last updated: January 27, 2010
Last verified: January 2009

March 7, 2008
January 27, 2010
January 2000
March 2003   (final data collection date for primary outcome measure)
  • Measurement of reflection and fluorescence spectra in vivo of sites in the human cervix [ Designated as safety issue: No ]
  • 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 [ Designated as safety issue: No ]
  • Validation of wavelength selections for the spectroscopy device derived from in vitro measurements [ Designated as safety issue: No ]
  • Sensitivity and specificity of this device for the diagnosis of cervical intraepithelial neoplasia [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00632190 on ClinicalTrials.gov Archive Site
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Spectroscopy in Diagnosing Dysplasia and Neoplasia in the Cervix in Women Undergoing Colposcopy
Measurement of Fluorescence EEM of Cervical Intraepithelial Neoplasia

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.

Interventional
Not Provided
Masking: Open Label
Primary Purpose: Diagnostic
  • Cervical Cancer
  • Precancerous Condition
  • Other: fluorophotometry
  • Procedure: colposcopic biopsy
  • Procedure: colposcopy
  • Procedure: light-scattering spectroscopy
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1800
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March 2003   (final data collection date for primary outcome measure)

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
Female
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
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NCT00632190
CDR0000581311, BCCR-C99-0441, C99-0441
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British Columbia Cancer Agency
National Cancer Institute (NCI)
Investigator: Sylvia Lam British Columbia Cancer Agency
National Cancer Institute (NCI)
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP