Study Stopped
Low accrual rate.
Digital Imaging Aid for Assessment of Cervical Dysplasia
Pilot Study of a Digital Imaging Aid for Assessment of Cervical Dysplasia
1 other identifier
observational
3
1 country
1
Brief Summary
The overall objective of this study is to evaluate whether polarized or green filtered digital imaging can assist clinicians to screen for premalignant lesions in the cervix. The specific aims of the study are:
- To compare polarized and green filtered digital images of the cervix, to standard white light images, colposcopic evaluation and to pathologic analysis of biopsied tissue.
- To develop algorithms to discriminate between normal and abnormal tissue based on digital images of the cervix.
- To analyze digital images to determine which types of optical information yield the most diagnostically useful data.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jun 2007
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2007
CompletedFirst Submitted
Initial submission to the registry
August 2, 2007
CompletedFirst Posted
Study publicly available on registry
August 6, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2009
CompletedAugust 1, 2012
July 1, 2012
1.9 years
August 2, 2007
July 31, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Evaluate whether a digital camera image can work as well as colposcopy at detecting precancerous tissue.
2 Year
Study Arms (1)
Digital Imaging Device
Patients with a diagnosis of cervical dysplasia that are scheduled for a colposcopy.
Interventions
Images of the cervix will be taken using different types of light and compared with the colposcopy procedure.
Eligibility Criteria
Patients with a diagnosis of cervical dysplasia that are scheduled for a colposcopy.
You may qualify if:
- Patients 18 years or older who are referred to the University of Texas MD Anderson Cancer Center Colposcopy Clinic for colposcopy are eligible for this study.
- Patients must sign an informed consent indicating awareness of the investigational nature of this study.
You may not qualify if:
- Patients who are pregnant are not eligible for this study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- M.D. Anderson Cancer Centerlead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
U.T.M.D. Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michele Follen, MD, PhD
M.D. Anderson Cancer Center
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 2, 2007
First Posted
August 6, 2007
Study Start
June 1, 2007
Primary Completion
May 1, 2009
Study Completion
May 1, 2009
Last Updated
August 1, 2012
Record last verified: 2012-07