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Digital Colposcopy in Finding Cervical Intraepithelial Neoplasia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00602368
First Posted: January 28, 2008
Last Update Posted: February 1, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
British Columbia Cancer Agency
  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: None (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 ]
    Measure normal and abnormal sites during colposcopy and compare this to pathology.


Enrollment: 114
Study Start Date: December 2010
Study Completion Date: May 2015
Primary Completion Date: December 2014 (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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00602368


Locations
Canada, British Columbia
BC Cancer Research Centre
Vancouver, British Columbia, Canada, V5Z 1L3
Sponsors and Collaborators
British Columbia Cancer Agency
National Cancer Institute (NCI)
Investigators
Principal Investigator: Dianne M. Miller, M.D. British Columbia Cancer Agency, Vancouver General Hospital
  More Information

Responsible Party: British Columbia Cancer Agency
ClinicalTrials.gov Identifier: NCT00602368     History of Changes
Other Study ID Numbers: CDR0000581286
BCCR-H03-61235 ( Other Identifier: UBC-BCCA REB )
P01CA082710 ( U.S. NIH Grant/Contract )
First Submitted: January 25, 2008
First Posted: January 28, 2008
Last Update Posted: February 1, 2017
Last Verified: January 2017

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