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
  Purpose

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.


Condition Intervention
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

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Measurement of Digital Colposcopy for Fluorescence Spectroscopy of Cervical Intraepithelial Neoplasia: A Pilot Study

Resource links provided by NLM:


Further study details as provided by British Columbia Cancer Agency:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 114
Study Start Date: December 2010
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00602368

Locations
Canada, British Columbia
BC Cancer Research Centre Recruiting
Vancouver, British Columbia, Canada, V5Z 1L3
Contact: Sylvia Lam    604-675-8093      
Sponsors and Collaborators
British Columbia Cancer Agency
Investigators
Principal Investigator: Dianne M. Miller, M.D. British Columbia Cancer Agency, Vancouver General Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: British Columbia Cancer Agency
ClinicalTrials.gov Identifier: NCT00602368     History of Changes
Other Study ID Numbers: CDR0000581286, BCCR-H03-61235, P01CA082710
Study First Received: January 25, 2008
Last Updated: October 29, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by British Columbia Cancer Agency:
cervical cancer
cervical intraepithelial neoplasia grade 1
cervical intraepithelial neoplasia grade 2
cervical intraepithelial neoplasia grade 3

Additional relevant MeSH terms:
Carcinoma in Situ
Cervical Intraepithelial Neoplasia
Neoplasms
Precancerous Conditions
Uterine Cervical Neoplasms
Carcinoma
Genital Diseases, Female
Genital Neoplasms, Female
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Urogenital Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Uterine Neoplasms

ClinicalTrials.gov processed this record on November 20, 2014