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

Not Applicable

Completed

• Conditions: Cervical Cancer; Precancerous Condition
• Interventions: Procedure: Colposcopic biopsy; Procedure: Light-Scattering Spectroscopy

• Registration Number: NCT00084903
• Lead Sponsor: M.D. Anderson Cancer Center

Brief 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.

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.

Study Timeline

• Study Start: 1998-04
• Study First Submitted: 2004-06-10
• Study First Submitted QC: 2004-06-10
• Study First Posted: 2004-06-11
• Primary Completion: 2007-07
• Study Completion: 2009-02
• Status Verified: 2012-08
• Last Update Submitted: 2012-08-01
• Last Update Posted: 2012-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1070

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Fluorescence Spectroscopy	Colposcopic biopsy	-
Fluorescence Spectroscopy	Light-Scattering Spectroscopy	-

Primary Outcome Measures

Name	Time	Method
Fluorescent Measurements of Cervix	Participation complete after readings of several 2.5 minutes fluorescent measurements and biopsies taken during colposcopy.	Two fluorescent measurements of cervix, approximately 2.5 minutes each: 1)colposcopically normal columnar site, and 2) a colposcopically normal squamous site.

Trial Locations

Locations (2)

British Columbia Cancer Agency - Vancouver Cancer Centre; 🇨🇦 Vancouver, British Columbia, Canada

M. D. Anderson Cancer Center at University of Texas; 🇺🇸 Houston, Texas, United States