Clinical Trial: Fluorescence and Reflectance Spectroscopy During Colposcopy in Detecting Cervical Intraepithelial Neoplasia and Dysplasia in Healthy Participants With a History of Normal Pap Smears

This study is currently recruiting patients.

Sponsors and Collaborators: M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)

Purpose

RATIONALE: New diagnostic procedures such as fluorescence and reflectance spectroscopy (shining light on tissue and measuring patterns of light reflected) may improve the ability to noninvasively detect cervical intraepithelial neoplasia and dysplasia.

PURPOSE: This diagnostic trial is studying how well fluorescence and reflectance spectroscopy during colposcopy work in detecting cervical intraepithelial neoplasia and dysplasia in healthy participants with a history of normal Pap smears.

Condition Treatment or Intervention
Cervical Cancer
 Procedure: colposcopic biopsy
 Procedure: diagnostic test
 Procedure: light-scattering spectroscopy

MedlinePlus related topics:  Cervical Cancer

Study Type: Interventional
Study Design: Diagnostic

Official Title: Diagnostic Study of Fluorescence and Reflectance Spectroscopy During Colposcopy for the Detection of Cervical Intraepithelial Neoplasia and Dysplasia in Healthy Participants With a History of Normal Pap Smears

Further Study Details: 

OBJECTIVES:

  • Identify potential improvements in noninvasive methods of diagnosing dysplasia and neoplasia of the cervix using fluorescence and reflectance spectroscopy in healthy participants with a history of normal pap smears.
  • Determine the reflection and fluorescence spectra of samples of the normal human cervix.
  • Refine the detection of cervical lesions by fluorescence spectroscopy in these participants using improved classification of normal columnar tissue and non-neoplastic tissue with inflammation.
  • Determine and validate the wavelength selections for spectroscopic diagnosis derived from measurements from these participants.
  • Compare specific tissue sections from these participants with their excitation-emission matrices in order to identify the cell types contributing to the signal.

OUTLINE: Participants undergo placement of a fiber optic probe on one normal columnar cell site and one normal squamous cell site of the cervix during colposcopy. The probe delivers laser light at a specific excitation wavelength and collects fluorescence from the entire emission wavelength range from the mucosa. Participants undergo biopsies of both sites.

PROJECTED ACCRUAL: A total of 1,000 participants will be accrued for this study.

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

DISEASE CHARACTERISTICS:

  • Healthy volunteers
  • History of normal pap smears

PATIENT CHARACTERISTICS: Age

  • 18 and over

Performance status

  • Not specified

Life expectancy

  • Not specified

Hematopoietic

  • Not specified

Hepatic

  • Not specified

Renal

  • Not specified

Other

  • Not pregnant

PRIOR CONCURRENT THERAPY: Biologic therapy

  • Not specified

Chemotherapy

  • Not specified

Endocrine therapy

  • Not specified

Radiotherapy

  • Not specified

Surgery

  • Not specified

Location and Contact Information


Texas
      MD Anderson Cancer Center at University of Texas, Houston,  Texas,  77030-4009,  United States; Recruiting
Michele Follen, MD, PhD  713-745-2564    mfollen@mdanderson.org 

Canada, British Columbia
      British Columbia Cancer Agency, Vancouver,  British Columbia,  V5Z 4E6,  Canada; Recruiting
J. Lawrence Benedet, MD  604-877-6000 ext. 2353 

Study chairs or principal investigators

Michele Follen, MD, PhD,  Study Chair,  M.D. Anderson Cancer Center   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000366944; MDA-GYN-97244; UTHSC-MS-99110; BCCA-CO2-0476; NCT00084903
Record last reviewed:  May 2004
Last Updated:  February 24, 2005
Record first received:  June 10, 2004
ClinicalTrials.gov Identifier:  NCT00084903
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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