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

Cervical Cancer Clinical Trial

Official title:

Pathological Correlation of Colposcopically Directed Biopsies to Fluorescence EEM of the Normal Human Cervix

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00084903
• Other study ID #: GYN97-244
• Secondary ID: P30CA016672MDA-G
• Status: Completed
• Phase: N/A
• First received: June 10, 2004
• Last updated: August 1, 2012
• Start date: April 1998
• Est. completion date: February 2009

Study information

• Verified date: August 2012
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1070
• Est. completion date: February 2009
• Est. primary completion date: July 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Cervical Cancer
• Cervical Intraepithelial Neoplasia
• Precancerous Condition
• Precancerous Conditions
• Uterine Cervical Neoplasms

Intervention

Procedure:
• Colposcopic biopsy
Two small samples of cervical tissue (biopsy) removed from 2 sites as spectroscopy readings.
• Light-Scattering Spectroscopy
Spectroscopy readings taken in 2 regions of cervix.

Locations

Country	Name	City	State
Canada	British Columbia Cancer Agency - Vancouver Cancer Centre	Vancouver	British Columbia
United States	M. D. Anderson Cancer Center at University of Texas	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fluorescent Measurements of Cervix	Two fluorescent measurements of cervix, approximately 2.5 minutes each: 1)colposcopically normal columnar site, and 2) a colposcopically normal squamous site.	Participation complete after readings of several 2.5 minutes fluorescent measurements and biopsies taken during colposcopy.	No

External Links

•   UT MD Anderson Cancer Center Website