Cervical Neoplasia Clinical Trial
Official title:
A Pilot Study: Measurement of Digital Colposcopy for Fluorescence Spectroscopy of the Normal Cervix for Screening, Using a Second Generation Device
Verified date | September 2009 |
Source | M.D. Anderson Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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:
1. 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.
2. 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).
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | February 2009 |
Est. primary completion date | February 2009 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Women 18 years of age or older. 2. 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. 3. Patients must sign an informed consent indicating awareness of the investigational nature of the study. Exclusion Criteria: 1. Patients will be considered ineligible if they are pregnant. 2. If they have a history of an abnormal Pap or a treatment to the cervix. |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
M.D. Anderson Cancer Center | National Cancer Institute (NCI) |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
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