Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Digital Colposcopy in Finding Cervical Intraepithelial Neoplasia

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by British Columbia Cancer Agency
Sponsor:
Collaborator:
Information provided by (Responsible Party):
British Columbia Cancer Agency
ClinicalTrials.gov Identifier:
NCT00602368
First received: January 25, 2008
Last updated: October 29, 2014
Last verified: October 2014

January 25, 2008
October 29, 2014
December 2010
January 2015   (final data collection date for primary outcome measure)
Feasibility of digital colposcopy & fluorescence spectroscopy as a tool for early diagnosis of CIN [ Time Frame: For length of study ] [ Designated as safety issue: No ]
Measure normal and abnormal sites during colposcopy and compare this to pathology.
  • Identification of potential improvements for a noninvasive method of diagnosing cervical dysplasia and neoplasia using digital colposcopy and fluorescence spectroscopic imaging [ Designated as safety issue: No ]
  • Measurement of fluorescence and reflectance images of the human cervix in vivo using digital colposcopy [ Designated as safety issue: No ]
  • Effect of acetic acid on the image contrast [ Designated as safety issue: No ]
  • Comparison of device performance with colposcopic impression and histopathologic interpretation of tissue removed by standard loop electrosurgical excision procedure (LEEP) [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00602368 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Digital Colposcopy in Finding Cervical Intraepithelial Neoplasia
Measurement of Digital Colposcopy for Fluorescence Spectroscopy of Cervical Intraepithelial Neoplasia: A Pilot Study

RATIONALE: Diagnostic procedures, such as digital colposcopy, may help doctors find and diagnose cervical intraepithelial neoplasia.

PURPOSE: This clinical trial is studying digital colposcopy to see how well it works in finding cervical intraepithelial neoplasia.

OBJECTIVES:

  • To identify potential improvements for a noninvasive method of diagnosing cervical dysplasia and neoplasia using digital colposcopy and fluorescence spectroscopic imaging.
  • To measure fluorescence and reflectance images of the human cervix in vivo using digital colposcopy.
  • To evaluate the effect of acetic acid on the image contrast obtained.
  • To compare the device performance with colposcopic impression and histopathologic interpretation of tissue removed by standard loop electrosurgical excision procedure (LEEP).

OUTLINE: This is a multicenter study.

Participants undergo routine colposcopy as part of their regular colposcopic evaluation. The digital colposcope is used to take fluorescence and reflectance images of the vagina and cervix. Participants also undergo loop electrosurgical excision procedure (LEEP). The digital colposcopic images are compared with tissue removed during LEEP. Additional surrogate biomarkers under development are also measured using tissue samples removed during LEEP, such as quantitative histopathology measurements, DNA tests for the copy number changes, and tests for the incorporation of viral HPV DNA.

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • Cervical Cancer
  • Precancerous Condition
  • Other: histological technique
  • Other: laboratory biomarker analysis
  • Procedure: colposcopic biopsy
  • Procedure: colposcopy
  • Procedure: light-scattering spectroscopy
  • Procedure: loop electrosurgical excision procedure
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
114
January 2016
January 2015   (final data collection date for primary outcome measure)

Criteria:

Inclusion criteria:

  • Included subjects will be ≥18 years old.
  • Included subjects will not be pregnant.
  • Included subjects will have a negative urine pregnancy test.
  • Included subjects will be scheduled for colposcopy and/or LEEP treatment at the VGH Women's Clinic.
  • Included subjects will indicate understanding of the study.
  • Included subjects will provide informed consent to participate.

Exclusion criteria:

  • Individuals <18 years old will be excluded.
  • Pregnant individuals will be excluded.
  • Individuals that have had an operation to remove their cervix will be excluded.

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
Female
19 Years and older
No
Canada
 
NCT00602368
CDR0000581286, BCCR-H03-61235, P01CA082710
No
British Columbia Cancer Agency
British Columbia Cancer Agency
National Cancer Institute (NCI)
Principal Investigator: Dianne M. Miller, M.D. British Columbia Cancer Agency, Vancouver General Hospital
British Columbia Cancer Agency
October 2014

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