Measurement of Digital Colposcopy for Fluorescence Spectroscopy of Cervical Intraepithelial Neoplasia

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00513123
First received: August 7, 2007
Last updated: July 31, 2012
Last verified: July 2012
  Purpose

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 Intervention
Cervical Cancer
Procedure: Colposcopy

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Pilot Study: Measurement of Digital Colposcopy for Fluorescence Spectroscopy of Cervical Intraepithelial Neoplasia

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 100
Study Start Date: September 2002
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Women 18 and older with an abnormal PAP.

Criteria

Inclusion Criteria:

  • Women 18 and older with an abnormal Pap

Exclusion Criteria:

  • Pregnant individuals will be excluded from this study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00513123

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

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00513123     History of Changes
Other Study ID Numbers: GYN98-258
Study First Received: August 7, 2007
Last Updated: July 31, 2012
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Neoplasms
Uterine Cervical Neoplasms
Cervical Intraepithelial Neoplasia
Carcinoma in Situ
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

ClinicalTrials.gov processed this record on April 16, 2014