Pathological Correlation of Colposcopically Directed Biopsies to Fluorescence EEM of the Normal Human Cervix
Colposcopic biopsy
+ Light-Scattering Spectroscopy
Urogenital Diseases+12
+ Genital Diseases
+ Uterine Cervical Diseases
Diagnostic Study
Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.1070 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Diagnostic Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.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
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy 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
M. D. Anderson Cancer Center at University of Texas
Houston, United StatesOpen M. D. Anderson Cancer Center at University of Texas in Google MapsBritish Columbia Cancer Agency - Vancouver Cancer Centre
Vancouver, Canada