- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00507182
Spectroscopy for Diagnostic Assessment of Oral Mucosal Lesions
Fluorescence and Reflectance Spectroscopy for Diagnostic Assessment of Oral Mucosal Lesions
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Abnormal-looking areas (lesions) inside the mouth may be a sign of cancer or changes that may lead to cancer. These lesions may need to be removed. Researchers are looking for a practical way to tell early on whether these lesions are cancer or may become cancer. This study will test a technique called fluorescence spectroscopy, which is under research in this study.
Each patient may have 1 to 5 lesions and several normal-looking areas inside the mouth exposed to a beam of light. The exposed tissues may emit very small amounts of light called fluorescence. This light is not seen by the eye but is detected by a computer. The small areas exposed to the light beam may then be removed.
The patients who need surgery may have the small tested areas removed when the lesions are surgically removed. A small sample from a normal-looking area may also be removed during surgery. Patients who do not need surgery may simply have small samples taken from the lesions and a normal-looking area in the clinic rather than in the operating room. The tissues will be looked at under a microscope to see whether they are cancerous. These results will be compared with the spectroscopy results.
If you are scheduled to participate in another MD Anderson study, Protocol 2008-0137 Entitled, "Phase Ib Study of Erlotinib Prior to Surgery in Patients with Head and Neck Cancer" (Study Chair: Dr. William William), some of your collected tissue samples may be shared with Dr. William for use on 2008-0137.
This is an investigational study. About 395 patients will be consented and screened for this study, with about 381 to take full part in this study. All will be treated at MD Anderson.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- University of Texas MD Anderson Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
1. Any person 18 years of age or older with a lesion of the oral mucosa. Persons with changes in existing lesions or those who develop new lesions can be re-evaluated, but it is not required.
Exclusion Criteria:
NA
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Fluorescence Spectroscopy
1-5 lesions + several normal-looking areas inside the mouth exposed to a beam of light; exposed tissues will emit very small amounts of fluorescence (light) then will be removed.
|
1-5 lesions + several normal-looking areas inside the mouth exposed to a beam of light; exposed tissues will emit very small amounts of fluorescence (light) then will be removed.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Classification of Oral Lesions
Time Frame: 11 Years
|
Distinguishing between normal and abnormal sites with four lesion classifications of normal, non-malignant inflammatory, dysplasia, and neoplasia.
|
11 Years
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HNS99-100
- NCI-2012-01601 (Registry Identifier: NCI CTRP)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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