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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00084903

Enrollment

1070

Registered

2004-06-11

Start date

1998-04-30

Completion date

2009-02-28

Last updated

2012-08-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Cancer, Precancerous Condition

Keywords

cervical cancer, cervical intraepithelial neoplasia

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.

Interventions

PROCEDUREColposcopic biopsy

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

PROCEDURELight-Scattering Spectroscopy

Spectroscopy readings taken in 2 regions of cervix.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Canada, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026