Spectroscopy in Diagnosing Dysplasia and Neoplasia in the Cervix in Women Undergoing Colposcopy

This study has been completed.

Sponsor:

Collaborator:

National Cancer Institute (NCI)

Information provided by:

National Cancer Institute (NCI)

ClinicalTrials.gov Identifier:

NCT00632190

First received: March 7, 2008

Last updated: January 27, 2010

Last verified: January 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

March 7, 2008

Last Updated Date

January 27, 2010

Start Date ^ICMJE

January 2000

Primary Completion Date

March 2003 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00632190 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Spectroscopy in Diagnosing Dysplasia and Neoplasia in the Cervix in Women Undergoing Colposcopy

Official Title ^ICMJE

Measurement of Fluorescence EEM of Cervical Intraepithelial Neoplasia

Brief Summary

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.

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.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Masking: Open Label
Primary Purpose: Diagnostic

Condition ^ICMJE

Cervical Cancer
Precancerous Condition

Intervention ^ICMJE

Other: fluorophotometry
Procedure: colposcopic biopsy
Procedure: colposcopy
Procedure: light-scattering spectroscopy

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

1800

Completion Date

Not Provided

Primary Completion Date

March 2003 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT00632190

Other Study ID Numbers ^ICMJE

CDR0000581311, BCCR-C99-0441, C99-0441

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

British Columbia Cancer Agency

Collaborators ^ICMJE

National Cancer Institute (NCI)

Investigators ^ICMJE

Investigator:

Sylvia Lam

British Columbia Cancer Agency

Information Provided By

National Cancer Institute (NCI)

Verification Date

January 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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