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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00632190
First Posted: March 10, 2008
Last Update Posted: January 28, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
  Purpose

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.


Condition Intervention
Cervical Cancer Precancerous Condition Other: fluorophotometry Procedure: colposcopic biopsy Procedure: colposcopy Procedure: light-scattering spectroscopy

Study Type: Interventional
Study Design: Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Measurement of Fluorescence EEM of Cervical Intraepithelial Neoplasia

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

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

Estimated Enrollment: 1800
Study Start Date: January 2000
Primary Completion Date: March 2003 (Final data collection date for primary outcome measure)
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00632190


Sponsors and Collaborators
British Columbia Cancer Agency
National Cancer Institute (NCI)
Investigators
OverallOfficial: Sylvia Lam British Columbia Cancer Agency
  More Information

ClinicalTrials.gov Identifier: NCT00632190     History of Changes
Other Study ID Numbers: CDR0000581311
BCCR-C99-0441
C99-0441
First Submitted: March 7, 2008
First Posted: March 10, 2008
Last Update Posted: January 28, 2010
Last Verified: January 2009

Keywords provided by National Cancer Institute (NCI):
cervical cancer
cervical intraepithelial neoplasia grade 1
cervical intraepithelial neoplasia grade 2
cervical intraepithelial neoplasia grade 3

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Neoplasms
Cervical Intraepithelial Neoplasia
Precancerous Conditions
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Carcinoma in Situ
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type