Squamous Cell Carcinoma of the Oral Cavity Clinical Trial
Official title:
Ex Vivo Multimodal Imaging of Upper Aerodigestive Epithelium
The purpose of this research study is to collect information on whether images made using investigational microscopes can improve researchers' ability to evaluate and distinguish between normal and abnormal areas in tissue samples surgically removed from patients with squamous cell carcinoma. The microscopes being used in this study are considered investigational because they have not been approved by the United States Food and Drug Administration (FDA) for finding abnormal or pre-cancerous areas.
Status | Completed |
Enrollment | 64 |
Est. completion date | May 2012 |
Est. primary completion date | May 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Subjects with biopsy-proven squamous cell carcinoma of the oral cavity, oropharynx, larynx, and/or hypopharynx. - Must be receiving surgical treatment for their cancer. Exclusion Criteria: • Presence of medical or psychiatric condition affecting ability to give voluntary, informed consent. |
Observational Model: Case-Only, Time Perspective: Cross-Sectional
Country | Name | City | State |
---|---|---|---|
United States | Mount Sinai School of Medicine | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Icahn School of Medicine at Mount Sinai | William Marsh Rice University |
United States,
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* Note: There are 16 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Accuracy and Interrater Reliability of HRME Image Interpretation | We will ask blinded raters to classify the HRME images as either benign (normal) or dysplastic/cancerous (abnormal) | baseline | No |
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