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Measurement of Digital Colposcopy for Fluorescence Spectroscopy of Cervical Intraepithelial Neoplasia: A Pilot Study

19 Years
Open (Enrolling)
Cervical Cancer, Precancerous Condition

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Trial Information

Measurement of Digital Colposcopy for Fluorescence Spectroscopy of Cervical Intraepithelial Neoplasia: A Pilot Study


- To identify potential improvements for a noninvasive method of diagnosing cervical
dysplasia and neoplasia using digital colposcopy and fluorescence spectroscopic

- 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

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.

Inclusion 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.


- See Disease Characteristics

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Principal Investigator

Thomas G Ehlen, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

BC Cancer Agency, Vancouver General Hospital


United States: Institutional Review Board

Study ID:




Start Date:

December 2010

Completion Date:

September 2014

Related Keywords:

  • Cervical Cancer
  • Precancerous Condition
  • cervical cancer
  • cervical intraepithelial neoplasia grade 1
  • cervical intraepithelial neoplasia grade 2
  • cervical intraepithelial neoplasia grade 3
  • Neoplasms
  • Uterine Cervical Neoplasms
  • Precancerous Conditions
  • Cervical Intraepithelial Neoplasia
  • Carcinoma in Situ