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
  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 Intervention
Cervical Cancer
Precancerous Condition
Procedure: Colposcopic biopsy
Procedure: Light-Scattering Spectroscopy

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Pathological Correlation of Colposcopically Directed Biopsies to Fluorescence EEM of the Normal Human Cervix

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • 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.


Enrollment: 1070
Study Start Date: April 1998
Study Completion Date: February 2009
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fluorescence Spectroscopy 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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00084903

Locations
United States, Texas
M. D. Anderson Cancer Center at University of Texas
Houston, Texas, United States, 77030-4009
Canada, British Columbia
British Columbia Cancer Agency - Vancouver Cancer Centre
Vancouver, British Columbia, Canada, V5Z 4E6
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Study Chair: Helen Rhodes, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00084903     History of Changes
Other Study ID Numbers: GYN97-244, P30CA016672, MDA-GYN-97244, UTHSC-HSC-MS-04-307, BCCA-RO2-1476, CDR0000366944
Study First Received: June 10, 2004
Last Updated: August 1, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:
cervical cancer
cervical intraepithelial neoplasia

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

ClinicalTrials.gov processed this record on September 30, 2014