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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1070 participants

Study Classification

INTERVENTIONAL

Study Start Date

1998-04-30

Study Completion Date

2009-02-28

Brief Summary

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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

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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.

Conditions

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Cervical Cancer Precancerous Condition

Keywords

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cervical cancer cervical intraepithelial neoplasia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Fluorescence Spectroscopy

Group Type EXPERIMENTAL

Colposcopic biopsy

Intervention Type PROCEDURE

Two small samples of cervical tissue (biopsy) removed from 2 sites as spectroscopy readings.

Light-Scattering Spectroscopy

Intervention Type PROCEDURE

Spectroscopy readings taken in 2 regions of cervix.

Interventions

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Colposcopic biopsy

Two small samples of cervical tissue (biopsy) removed from 2 sites as spectroscopy readings.

Intervention Type PROCEDURE

Light-Scattering Spectroscopy

Spectroscopy readings taken in 2 regions of cervix.

Intervention Type PROCEDURE

Other Intervention Names

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biopsy Spectroscopy Fluorescence spectroscopy

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Helen Rhodes, MD

Role: STUDY_CHAIR

M.D. Anderson Cancer Center

Locations

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M. D. Anderson Cancer Center at University of Texas

Houston, Texas, United States

Site Status

British Columbia Cancer Agency - Vancouver Cancer Centre

Vancouver, British Columbia, Canada

Site Status

Countries

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United States Canada