Clinical trial NCT00084903: Fluorescence and Reflectance Spectroscopy During Colposcopy in Detecting Cervical Intraepithelial Neoplasia and Dysplasia in Healthy Participants With a History of Normal Pap Smears
Official title: Pathological Correlation of Colposcopically Directed Biopsies to Fluorescence EEM of the Normal Human Cervix
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Cancer
Precancerous Condition
Keywords: cervical cancer
cervical intraepithelial neoplasia
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2004-06-11
Enrollment: 1070
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Fluorescent Measurements of Cervix
timeFrame: Participation complete after readings of several 2.5 minutes fluorescent measurements and biopsies taken during colposcopy.
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: M. D. Anderson Cancer Center at University of Texas
state: Texas
city: Vancouver
country: Canada
facility: British Columbia Cancer Agency - Vancouver Cancer Centre
state: British Columbia
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Helen Rhodes, MD
role: STUDY_CHAIR
References: