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CytID Analysis of Oral Lesions

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ClinicalTrials.gov Identifier: NCT03555721
Recruitment Status : Recruiting
First Posted : June 13, 2018
Last Update Posted : June 13, 2018
Sponsor:
Collaborator:
M.D. Anderson Cancer Center
Information provided by (Responsible Party):
Mark Nichols, The University of Texas Health Science Center, Houston

Brief Summary:
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.

Condition or disease Intervention/treatment
Oral Cavity Cancer Oropharyngeal Cancer Other: Oral examination with incandescent light Other: Oral examination with OralID Diagnostic Test: Biopsy Diagnostic Test: CytID Diagnostic Test: hpvID

Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: CytID Analysis of Oral Lesions
Estimated Study Start Date : June 13, 2018
Estimated Primary Completion Date : November 1, 2019
Estimated Study Completion Date : November 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Group/Cohort Intervention/treatment
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
Other: Oral examination with incandescent light
Suspicious oral lesions will be identified by oral examination with incandescent light.

Other: 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.

Diagnostic Test: Biopsy
Tissue will be collected to identify pre-cancerous or cancerous cells

Diagnostic Test: 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.

Diagnostic Test: 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.




Primary Outcome Measures :
  1. Number of participants for whom biopsy and CytID results both indicate presence of malignant or premalignant oral lesions [ Time Frame: day 1 (at the time of oral examination) ]
  2. Number of participants for whom biopsy indicates presence of malignant or premalignant oral lesions and hpvID indicates presence of HPV [ Time Frame: day 1 (at the time of oral examination) ]
  3. Number of participants for whom biopsy results, but not CytID results, indicate presence of malignant or premalignant oral lesions [ Time Frame: day 1 (at the time of oral examination) ]
  4. Number of participants for whom CytID results, but not biopsy results, indicate presence of malignant or premalignant oral lesions [ Time Frame: day 1 (at the time of oral examination) ]
  5. Number of participants for whom biopsy does not indicate presence of malignant or premalignant oral lesions, but hpvID indicates presence of HPV [ Time Frame: day 1 (at the time of oral examination) ]
  6. Number of participants for whom biopsy indicates presence of malignant or premalignant oral lesions, but hpvID does not indicate presence of HPV [ Time Frame: day 1 (at the time of oral examination) ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
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).
Criteria

Inclusion Criteria:

  • Receive care at the Avenue 360 Health and Wellness Clinic, a not for profit dental clinic in the Montrose area of Houston
  • Present with a potentially malignant oral lesion (PMOL) for whom a biopsy is deemed necessary

Exclusion Criteria:

  • Do not receive care at the Avenue 360 Health and Wellness Clinic, a not for profit dental clinic in the Montrose area of Houston
  • Do not present with a potentially malignant oral lesion (PMOL) for whom a biopsy is deemed necessary

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03555721


Contacts
Contact: Clifton M Nichols, DDS 713-341-3793 mnichols@avenue360.org

Locations
United States, Texas
The University of Texas Health Science Center at Houston Recruiting
Houston, Texas, United States, 77030
Contact: Clifton M Nichols, DDS    713-341-3793    mnichols@avenue360.org   
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Clifton M Nichols, DDS The University of Texas Health Science Center, Houston

Responsible Party: Mark Nichols, Clinical Associate Professor, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT03555721     History of Changes
Other Study ID Numbers: HSC-GEN-17-1067
First Posted: June 13, 2018    Key Record Dates
Last Update Posted: June 13, 2018
Last Verified: June 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Oropharyngeal Neoplasms
Mouth Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Mouth Diseases