Measurement of Digital Colposcopy for Fluorescence Spectroscopy of Cervical Intraepithelial Neoplasia

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. Identifier: NCT00513123
Recruitment Status : Completed
First Posted : August 8, 2007
Last Update Posted : August 1, 2012
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:

The overall objective of this study is to identify potential improvements for a noninvasive method of diagnosing dysplasia and neoplasia in the cervix using digital colposcopy for colposcopy for fluorescence spectroscopy.

Other Objectives:

  • To measure digital fluorescence and reflectance images in vivo of sites in the human cervix.
  • To evaluate the effect of acetic acid in the image contrast obtained.
  • Compare the device performance to colposcopy and pathologic analysis of tissue removed at colposcopy.

Condition or disease Intervention/treatment
Cervical Cancer Procedure: Colposcopy

Detailed Description:

DCF may provide a better way to detect or treat lesions of the cervix. Women in the study will already be scheduled for colposcopy to detect or treat lesions of the cervix. (A colposcopy is an exam of the vagina and cervix using a magnifying lens).

DCF will be done during the routine colposcopy in the outpatient clinic. A digital colposcope (DC) device will be used to take a sequence of images of the cervix and vagina. (A DC is a digital camera connected to the colposcope with a specialized light source. It will shine light on the cervix and acquire a sequence images). The images will tell doctors about the cells and structure of the tissue. After the first set of images, acetic acid will be applied to the cervix so that lesions show up better, and 1-2 minutes later more readings will be taken.

Small samples of areas of abnormal tissue will be removed during colposcopy. Taking these tissue samples is a routine part of this type of exam. If patients are having colposcopy and loop electrosurgical excision procedure (LEEP treatment, one sample of normal tissue will be taken. (The cervix will be numbed for this procedure.) DCF images will be compared with lab findings from these samples. Before DCF is done, as standard of care, patients will have a complete history and physical exam, urine pregnancy test, pap smear, and cultures for gonorrhea, chlamydia and viral testing.

This is an investigational study. About 114 women will take part in this study. About 22 will be enrolled at M. D. Anderson.

Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Pilot Study: Measurement of Digital Colposcopy for Fluorescence Spectroscopy of Cervical Intraepithelial Neoplasia
Study Start Date : September 2002
Actual Primary Completion Date : February 2009
Actual Study Completion Date : February 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
Digital Colposcopy
Digital Colposcopy for Fluorescence (DCF)
Procedure: Colposcopy
As part of routine colposcopic evaluation, patients will undergo routine colposcopy with the digital colposcope (DC) will then be used to take an image of the vagina and cervix.

Primary Outcome Measures :
  1. To study whether digital colposcopy for fluorescence (DCF) can perform better than standard methods to detect cancer of the cervix or precancerous lesions. [ Time Frame: 7 Years ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women 18 and older with an abnormal PAP.

Inclusion Criteria:

  • Women 18 and older with an abnormal Pap

Exclusion Criteria:

  • Pregnant individuals will be excluded from this study

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 identifier (NCT number): NCT00513123

United States, Texas
Lyndon B. Johnson Hospital
Houston, Texas, United States, 77030
U.T. Health Science Center
Houston, Texas, United States, 77030
U.T.M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
Canada, British Columbia
British Columbia Cancer Research Center
Vancouver, British Columbia, Canada
University College Hospital
Ibadan, Oyo State, Nigeria
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Principal Investigator: Michele Follen, MD, PhD M.D. Anderson Cancer Center

Additional Information:
Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00513123     History of Changes
Other Study ID Numbers: GYN98-258
First Posted: August 8, 2007    Key Record Dates
Last Update Posted: August 1, 2012
Last Verified: July 2012

Keywords provided by M.D. Anderson Cancer Center:
Digital Colposcopy for Fluorescence
Fluorescence Spectroscopy
Digital Colposcopy
Cervical Intraepithelial Neoplasia
Cervical Cancer
Lesions of the cervix
Precancerous lesions

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