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Measurement of Fluorescence EEM of Cervical Intraepithelial Neoplasia


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

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Trial Information

Measurement of Fluorescence EEM of Cervical Intraepithelial Neoplasia


OBJECTIVES:

- To identify potential improvements for a noninvasive method of diagnosing dysplasia and
neoplasia in the cervix using fluorescence and reflectance spectroscopy.

- To measure the reflection and fluorescence spectra in vivo of sites in the human
cervix.

- To further refine fluorescence spectroscopy for detection of cervical lesions via
better classification of normal columnar tissue and non-neoplastic tissue with
inflammation, and low- and high-grade squamous intraepithelial lesions.

- Evaluate and validate the wavelength selections for the spectroscopy device derived
from in vitro measurements.

- Determine the sensitivity and specificity of this device for the diagnosis of cervical
intraepithelial neoplasia.

OUTLINE: This is a multicenter study. Patients are stratified according to menopausal status
and current treatment (premenopausal not on oral contraceptive pills [OCP] vs premenopausal
on OCP vs postmenopausal not on hormone replacement therapy [HRT] vs postmenopausal on HRT).

- Diagnostic study: As part of routine colposcopic evaluation, patients undergo placement
of the probe on 1 to 4 sites in the cervix for 2-5 minutes. Up to two colposcopically
abnormal sites and two normal sites are biopsied. Blood is drawn for hormone levels.
Fluorescence excitation and emission matrix (EEM) data and reflectance spectroscopic
information is acquired from patients with an abnormal Papanicolaou smear.

- Screening study: Fluorescence EEM and reflectance spectroscopic information is acquired
from patients with a history of normal Papanicolaou smears.

PROJECTED ACCRUAL: A total of 800 patients with abnormal Papanicolaou smears and 1000
subjects with normal Papanicolaou smears are accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Referred to the Colposcopy clinic at Vancouver General Hospital, the MD Anderson
Cancer Center, or the University of Texas at Austin

- Abnormal or normal Papanicolaou smear

- Hormone receptor status not specified

PATIENT CHARACTERISTICS:

- Pre or post-menopausal

- Not pregnant

PRIOR CONCURRENT THERAPY:

- Not specified

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Measurement of reflection and fluorescence spectra in vivo of sites in the human cervix

Safety Issue:

No

Principal Investigator

Sylvia Lam

Investigator Affiliation:

British Columbia Cancer Agency

Authority:

United States: Federal Government

Study ID:

CDR0000581311

NCT ID:

NCT00632190

Start Date:

January 2000

Completion Date:

Related Keywords:

  • Cervical Cancer
  • Precancerous Condition
  • cervical cancer
  • cervical intraepithelial neoplasia grade 1
  • cervical intraepithelial neoplasia grade 2
  • cervical intraepithelial neoplasia grade 3
  • Neoplasms
  • Uterine Cervical Neoplasms
  • Precancerous Conditions
  • Cervical Intraepithelial Neoplasia
  • Carcinoma in Situ

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