Completed

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

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What is being tested

Colposcopic biopsy

+ Light-Scattering Spectroscopy

Procedure
Who is being recruted

Urogenital Diseases+12

+ Genital Diseases

+ Uterine Cervical Diseases

Over 18 Years
+3 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Diagnostic Study

Interventional
Study Start: April 1998
See protocol details

Summary

Principal SponsorM.D. Anderson Cancer Center
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 1998

Actual date on which the first participant was enrolled.

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.

Official TitlePathological Correlation of Colposcopically Directed Biopsies to Fluorescence EEM of the Normal Human Cervix
NCT00084903
Principal SponsorM.D. Anderson Cancer Center
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

1070 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Diagnostic Study

Diagnostic studies focus on improving how we detect or confirm a disease. They test new tools or techniques that could provide faster or more accurate diagnoses.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesGenital DiseasesUterine Cervical DiseasesUterine Cervical DysplasiaUterine Cervical NeoplasmsFemale Urogenital Diseases and Pregnancy ComplicationsGenital Diseases, FemaleGenital Neoplasms, FemaleNeoplasmsNeoplasms by SitePrecancerous ConditionsUrogenital NeoplasmsUterine DiseasesUterine NeoplasmsFemale Urogenital Diseases

Criteria

2 inclusion criteria required to participate
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.

Subjects must sign an informed consent indicating awareness of the investigational nature of this study.

1 exclusion criteria prevent from participating
1) Pregnant individuals will be ineligible for this study.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Suspended

M. D. Anderson Cancer Center at University of Texas

Houston, United StatesOpen M. D. Anderson Cancer Center at University of Texas in Google Maps
Suspended

British Columbia Cancer Agency - Vancouver Cancer Centre

Vancouver, Canada
Completed2 Study Centers