Spectroscopy in Diagnosing Dysplasia and Neoplasia in the Cervix in Women Undergoing Colposcopy - Full Text View

Sponsors and Collaborators:	British Columbia Cancer Agency National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00632190

Purpose

RATIONALE: New diagnostic procedures, such as spectroscopy, may be a less invasive way to check for dysplasia and neoplasia in the cervix. Spectroscopy may also used as a screening test to help doctors find cervical cancer sooner, when it may be easier to treat.

PURPOSE: This clinical trial is studying how well spectroscopy works in diagnosing dysplasia and neoplasia in the cervix in women undergoing colposcopy or Pap testing.

Condition	Intervention
Cervical Cancer Precancerous/Nonmalignant Condition	Other: fluorophotometry Procedure: colposcopic biopsy Procedure: colposcopy Procedure: light-scattering spectroscopy

Study Type:	Interventional
Study Design:	Diagnostic, Open Label
Official Title:	Measurement of Fluorescence EEM of Cervical Intraepithelial Neoplasia

Resource links provided by NLM:

MedlinePlus related topics: Cancer

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Measurement of reflection and fluorescence spectra in vivo of sites in the human cervix [ Designated as safety issue: No ]
Refinement of 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 [ Designated as safety issue: No ]
Validation of wavelength selections for the spectroscopy device derived from in vitro measurements [ Designated as safety issue: No ]
Sensitivity and specificity of this device for the diagnosis of cervical intraepithelial neoplasia [ Designated as safety issue: No ]

Estimated Enrollment:	1800
Study Start Date:	January 2000
Primary Completion Date:	March 2003 (Final data collection date for primary outcome measure)

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00632190

Sponsors and Collaborators

British Columbia Cancer Agency

National Cancer Institute (NCI)

Investigators

Investigator:

Sylvia Lam

British Columbia Cancer Agency

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000581311, BCCR-C99-0441, C99-0441
Study First Received:	March 7, 2008
Last Updated:	June 27, 2009
ClinicalTrials.gov Identifier:	NCT00632190 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

cervical cancer
cervical intraepithelial neoplasia grade 1
cervical intraepithelial neoplasia grade 2
cervical intraepithelial neoplasia grade 3

Study placed in the following topic categories:

Precancerous Conditions
Carcinoma in Situ
Neoplasms, Glandular and Epithelial
Carcinoma
Cervical Intraepithelial Neoplasia

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Precancerous Conditions
Carcinoma in Situ

Neoplasms, Glandular and Epithelial
Carcinoma
Cervical Intraepithelial Neoplasia

ClinicalTrials.gov processed this record on September 10, 2009