Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
18 participants
OBSERVATIONAL
2018-05-30
2022-11-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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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
Oral examination with incandescent light
Suspicious oral lesions will be identified by oral examination with incandescent light.
Oral examination with OralID
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.
Biopsy
Tissue will be collected to identify pre-cancerous or cancerous cells
CytID
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
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.
Interventions
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Oral examination with incandescent light
Suspicious oral lesions will be identified by oral examination with incandescent light.
Oral examination with OralID
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.
Biopsy
Tissue will be collected to identify pre-cancerous or cancerous cells
CytID
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
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.
Eligibility Criteria
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Inclusion Criteria
* Present with a potentially malignant oral lesion (PMOL) for whom a biopsy is deemed necessary
Exclusion Criteria
* Do not present with a potentially malignant oral lesion (PMOL) for whom a biopsy is deemed necessary
18 Years
80 Years
ALL
Yes
Sponsors
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M.D. Anderson Cancer Center
OTHER
The University of Texas Health Science Center, Houston
OTHER
Responsible Party
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Mark Nichols
Clinical Associate Professor
Principal Investigators
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Clifton M Nichols, DDS
Role: PRINCIPAL_INVESTIGATOR
The University of Texas Health Science Center, Houston
Locations
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The University of Texas Health Science Center at Houston
Houston, Texas, United States
Countries
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Other Identifiers
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HSC-GEN-17-1067
Identifier Type: -
Identifier Source: org_study_id
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