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 has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00084903
First received: June 10, 2004
Last updated: August 1, 2012
Last verified: August 2012

June 10, 2004
August 1, 2012
April 1998
July 2007   (final data collection date for primary outcome measure)
Fluorescent Measurements of Cervix [ Time Frame: Participation complete after readings of several 2.5 minutes fluorescent measurements and biopsies taken during colposcopy. ] [ Designated as safety issue: No ]
Two fluorescent measurements of cervix, approximately 2.5 minutes each: 1)colposcopically normal columnar site, and 2) a colposcopically normal squamous site.
Not Provided
Complete list of historical versions of study NCT00084903 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Fluorescence and Reflectance Spectroscopy During Colposcopy in Detecting Cervical Intraepithelial Neoplasia and Dysplasia in Healthy Participants With a History of Normal Pap Smears
Pathological Correlation of Colposcopically Directed Biopsies to Fluorescence EEM of the Normal Human Cervix

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.

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 in vivo 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 in vitro 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.

NOTE: *The columnar epithelium will not be colposcopically visible in all patients, in which case 2 normal squamous sites will be measured

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

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • Cervical Cancer
  • Precancerous Condition
  • Procedure: Colposcopic biopsy
    Two small samples of cervical tissue (biopsy) removed from 2 sites as spectroscopy readings.
    Other Name: biopsy
  • Procedure: Light-Scattering Spectroscopy
    Spectroscopy readings taken in 2 regions of cervix.
    Other Names:
    • Spectroscopy
    • Fluorescence spectroscopy
Experimental: Fluorescence Spectroscopy
Interventions:
  • Procedure: Colposcopic biopsy
  • Procedure: Light-Scattering Spectroscopy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1070
February 2009
July 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Subjects will be individuals 18 years of age or older, who have voluntarily responded to advertisement in the form of posted flyers or word of mouth.
  2. Subjects must sign an informed consent indicating awareness of the investigational nature of this study.

Exclusion Criteria:

1) Pregnant individuals will be ineligible for this study.

Female
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Canada,   United States
 
NCT00084903
GYN97-244, P30CA016672, MDA-GYN-97244, UTHSC-HSC-MS-04-307, BCCA-RO2-1476, CDR0000366944
No
M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Study Chair: Helen Rhodes, MD M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
August 2012

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