Measurement of Digital Colposcopy for Fluorescence Spectroscopy of Cervical Intraepithelial Neoplasia

Completed

• Conditions: Cervical Cancer
• Interventions: Procedure: Colposcopy

• Registration Number: NCT00513123
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2002-09
• Study First Submitted: 2007-08-07
• Study First Submitted QC: 2007-08-07
• Study First Posted: 2007-08-08
• Primary Completion: 2009-02
• Study Completion: 2009-02
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-31
• Last Update Posted: 2012-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

• Women 18 and older with an abnormal Pap

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Exclusion Criteria

• Pregnant individuals will be excluded from this study

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Digital Colposcopy	Colposcopy	Digital Colposcopy for Fluorescence (DCF)

Primary Outcome Measures

Name	Time	Method
To study whether digital colposcopy for fluorescence (DCF) can perform better than standard methods to detect cancer of the cervix or precancerous lesions.	7 Years

Trial Locations

Locations (5)

University College Hospital; 🇳🇬 Ibadan, Oyo State, Nigeria

British Columbia Cancer Research Center; 🇨🇦 Vancouver, British Columbia, Canada

U.T. Health Science Center; 🇺🇸 Houston, Texas, United States

U.T.M.D. Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

Lyndon B. Johnson Hospital; 🇺🇸 Houston, Texas, United States