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

M.D. Anderson Cancer Center

Status: Completed

Conditions: Precancerous Condition; Cervical Cancer

Treatments: Procedure: Light-Scattering Spectroscopy; Procedure: Colposcopic biopsy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00084903

CDR0000366944 (Registry Identifier)

P30CA016672 (U.S. NIH Grant/Contract)

BCCA-RO2-1476

UTHSC-HSC-MS-04-307

MDA-GYN-97244 (Other Identifier)

GYN97-244

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,070 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,070 participants in 1 patient group

Fluorescence Spectroscopy

Experimental group

Treatment:

Procedure: Colposcopic biopsy

Procedure: Light-Scattering Spectroscopy