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Completed

NCT Number: NCT00632190

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

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.

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Key information

Conditions

Cervical Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Precancerous Condition Precancerous Conditions Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Dysplasia Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

fluorophotometry

Other

colposcopic biopsy

Procedure

colposcopy

Procedure

light-scattering spectroscopy

Procedure

Primary outcomes

  1. Measurement of reflection and fluorescence spectra in vivo of sites in the human cervix

  2. 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

  3. Validation of wavelength selections for the spectroscopy device derived from in vitro measurements

  4. Sensitivity and specificity of this device for the diagnosis of cervical intraepithelial neoplasia

Sponsors and collaborators

Lead sponsor

British Columbia Cancer Agency

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Measurement of Fluorescence EEM of Cervical Intraepithelial Neoplasia

Important dates

Study start
2000
Primary completion
2003
First posted
Mar 10, 2008
Registry last updated
Jan 28, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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