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low subject recruitment
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| Name | Class |
|---|---|
| M.D. Anderson Cancer Center | OTHER |
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The purpose of this study is to correlate the results from a standard of care biopsy with CytID™ and hpvID™ swab tests for potentially premalignant and malignant oral lesions. The biopsy is considered standard of care and will be performed regardless of the patient's enrollment in the study. The study-related data gathering will not influence the treatment decisions of the clinician.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral examination followed by biopsy, CytID, and hpvID | Identification of oral lesions with oral examination with both incandescent light and fluorescent light (OralID), and subsequent testing of suspicious oral lesions with biopsy, CytID, and hpvID |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral examination with incandescent light | Other | Suspicious oral lesions will be identified by oral examination with incandescent light. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of participants for whom biopsy and CytID results both indicate presence of malignant or premalignant oral lesions | day 1 (at the time of oral examination) | |
| Number of participants for whom biopsy indicates presence of malignant or premalignant oral lesions and hpvID indicates presence of HPV | day 1 (at the time of oral examination) | |
| Number of participants for whom biopsy results, but not CytID results, indicate presence of malignant or premalignant oral lesions | day 1 (at the time of oral examination) | |
| Number of participants for whom CytID results, but not biopsy results, indicate presence of malignant or premalignant oral lesions | day 1 (at the time of oral examination) | |
| Number of participants for whom biopsy does not indicate presence of malignant or premalignant oral lesions, but hpvID indicates presence of HPV | day 1 (at the time of oral examination) | |
| Number of participants for whom biopsy indicates presence of malignant or premalignant oral lesions, but hpvID does not indicate presence of HPV | day 1 (at the time of oral examination) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who receive care at the Avenue 360 Health and Wellness Clinic, a not for profit dental clinic in the Montrose area of Houston (a federally qualified health center).
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| Name | Affiliation | Role |
|---|---|---|
| Clifton M Nichols, DDS | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
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| ID | Term |
|---|---|
| D009062 | Mouth Neoplasms |
| D009959 | Oropharyngeal Neoplasms |
| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009059 | Mouth Diseases |
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| ID | Term |
|---|---|
| D003945 | Diagnosis, Oral |
| D001706 | Biopsy |
| ID | Term |
|---|---|
| D003813 | Dentistry |
| D003581 | Cytodiagnosis |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
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| Oral examination with OralID | Other | OralID uses a proven, optically based fluorescence technology that provides the clinician an aid in visualization of oral cancer, pre-cancer and other abnormal lesions. |
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| Biopsy | Diagnostic Test | Tissue will be collected to identify pre-cancerous or cancerous cells |
|
| CytID | Diagnostic Test | CytID™ is an adjunctive process that is a noninvasive, pain-free, chair-side procedure for assessment of suspicious oral cavity lesions using a brush swab. The test is based on an objective measure of gross changes in the nuclear DNA content of oral epithelial cells; thereby, providing information about the pre-cancerous or cancerous state of a lesion. |
|
| hpvID | Diagnostic Test | hpvID™ testing can detect all major HPV types and shows the current HPV status of the patient. This provides additional clinical information to correlate and compare hpvID™ trends with routine standard of care biopsy or cytology results. |
|
| D009057 |
| Stomatognathic Diseases |
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D010608 | Pharyngeal Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D019937 |
| Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D013048 | Specimen Handling |
| D003949 | Diagnostic Techniques, Surgical |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |