Measurement of Digital Colposcopy for Fluorescence Spectroscopy of TNC Using a Second Device

Study Overview
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Brief Summary
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The overall objective of this study is to identify potential improvements for a noninvasive method of diagnosing dysplasia and neoplasia in the cervix using Multi-spectral Digital Colposcopy (MDC), a device that uses fluorescence and reflectance spectroscopy to compare images to histopathologic mapping of the cervical epithelium. Primary Objective: -To measure Multi-spectral Digital Colposcopy images in vivo of the cervix both before and after acetic acid in a screening population.This is a second generation research device with low significant risk for which we are studying MDC. Secondary Objectives: To evaluate the effect of the fading of acetic acid in the image contrast obtained over time to see if this fading can predict the presence of any neoplasia. To evaluate mapping the cervix so that software can reconstruct the cervical epithelial map as evaluated by a Papanicolaou Smear to compare to routine colposcopic images as well as those from the Multi-spectral Digital Colposcopy (MDC).

Detailed Description
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A colposcopy is an exam of the vagina and cervix using a magnifying lens. A multi-spectral digital colposcopy uses a digital camera and a special light to take pictures of the cervix and vagina. Before taking part in this study, you will have a complete medical history recorded. You will have a physical exam and a pap smear. Women who are able to have children must have a negative urine pregnancy test. You will then have a multi-spectral digital colposcopy performed during the routine colposcopy in the outpatient clinic. A multi-spectral digital colposcopy device will shine light on the cervix and vagina and take several pictures. The pictures will be used by the doctors to check the cells and structure of the tissue. After the first set of pictures, acetic acid (vinegar) will be applied to the cervix so any lesions would show up better. Application of acetic acid is a normal part of the colposcopy and not part of the research. About 1-2 minutes later, more pictures will be taken. If the acetic acid/colposcopy show abnormal cells, you will have a biopsy of the cervical canal. If the acetic acid /colposcopy show normal cells, no biopsy will be taken. Once you have completed the colposcopy with or without the biopsy of the cervical canal, your participation on this study is complete. If either your Pap smear or biopsy of the cervical canal is abnormal, the study doctor/staff will recommend further care or treatment.

Official Title
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A Pilot Study: Measurement of Digital Colposcopy for Fluorescence Spectroscopy of the Normal Cervix for Screening, Using a Second Generation Device

Conditions
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Cervical Neoplasia

Intervention / Treatment
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* Procedure: Multi-spectral Digital Colposcopy (MDC)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women 18 years of age or older. Women who have been referred for screening at U.T.M.D. Anderson Hospital, Houston, TX USA; U.T. Health Science Center-Houston,TX USA; Lyndon B. Johnson General Hospital, Houston, TX USA; British Columbia Cancer Agency, Vancouver, British Columbia, Canada; and the University College Hospital, Ibadan, Oyo State, Nigeria, Africa Cervical Screening Clinics, Family Planning Clinics or Gynecology Clinics. Patients must sign an informed consent indicating awareness of the investigational nature of the study. Exclusion Criteria: Patients will be considered ineligible if they are pregnant. If they have a history of an abnormal Pap or a treatment to the cervix.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MDC<br>Multi-spectral Digital Colposcopy for Fluorescence Spectroscopy | Procedure: Multi-spectral Digital Colposcopy (MDC)<br>* Use of a digital camera and a special light to take pictures of the cervix and vagina.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with abnormal cell detection before and after acetic acid/colposcopy using Multi-spectral Digital Colposcopy (MDC) | Measurements of normal sites during colposcopy before and after the application of acetic acid using Multi-spectral Digital Colposcopy (MDC) images in vivo of the cervix both before and after acetic acid. Three images (white, blue, and green light) compared before and after acetic acid placement, the images may be compared to pathology obtained from a Pap Smear taken to evaluate the performance of the instrument. | Participation limited to Colposcopy visit, anticipate study completion in one day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cervix, Cervical dysplasia, Cervical neoplasia, Cervical intraepithelial neoplasia, Multi-spectral Digital Colposcopy, MDC, Acetic acid, Colposcopy, Spectroscopy, Fluorescence Spectroscopy, Abnormal Pap Smear