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


N/A
18 Years
N/A
Not Enrolling
Female
Cervical Cancer, Precancerous Condition

Thank you

Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Fluorescent Measurements of Cervix

Outcome Description:

Two fluorescent measurements of cervix, approximately 2.5 minutes each: 1)colposcopically normal columnar site, and 2) a colposcopically normal squamous site.

Outcome Time Frame:

Participation complete after readings of several 2.5 minutes fluorescent measurements and biopsies taken during colposcopy.

Safety Issue:

No

Principal Investigator

Helen Rhodes, MD

Investigator Role:

Study Chair

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

GYN97-244

NCT ID:

NCT00084903

Start Date:

April 1998

Completion Date:

February 2009

Related Keywords:

  • Cervical Cancer
  • Precancerous Condition
  • cervical cancer
  • cervical intraepithelial neoplasia
  • Uterine Cervical Neoplasms
  • Precancerous Conditions
  • Cervical Intraepithelial Neoplasia
  • Carcinoma in Situ

Name

Location
M. D. Anderson Cancer Center at University of Texas Houston, Texas  77030-4009