Oral Cavity CancerNCT03555721
CytID Analysis of Oral Lesions
An observational study of Oral Cavity Cancer and Oropharyngeal Cancer, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Oral Cavity Cancer, Oropharyngeal Cancer
- What is being tested?
- Oral examination with incandescent light, Oral examination with OralID and Biopsy
- Type of treatment
- Pill or oral medicine
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 30 May 2018to 1 Nov 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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).
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
About this study
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.
- Conditions
- Oral Cavity Cancer, Oropharyngeal Cancer
- Being tested
- Oral examination with incandescent light, Oral examination with OralID, Biopsy, CytID, hpvID
- Medical subject headings
- Mouth Neoplasms, Oropharyngeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral examination with incandescent lightOther
Suspicious oral lesions will be identified by oral examination with incandescent light.
Oral examination with OralIDOther
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.
BiopsyDiagnostic test
Tissue will be collected to identify pre-cancerous or cancerous cells
CytIDDiagnostic 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.
hpvIDDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Oral examination with incandescent light; Other: Oral examination with OralID; Diagnostic Test: Biopsy; Diagnostic Test: CytID; Diagnostic Test: hpvID |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants for whom biopsy and CytID results both indicate presence of malignant or premalignant oral lesions
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: day 1 (at the time of oral examination)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2018
- Study start30 May 2018
- Primary completion1 Nov 2022
- Study completion1 Nov 2022
Why it stopped: low subject recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral Cavity CancerStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- M.D. Anderson Cancer Center
- Responsible party
- Principal investigator, Mark Nichols, The University of Texas Health Science Center, Houston
- Investigators
- Clifton M Nichols, DDS, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03555721
- Sponsor's protocol ID
- HSC-GEN-17-1067
- Status last verified
- May 2023
- First submitted
- 29 May 2018
- Last updated
- 10 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CytID Analysis of Oral Lesions
- ClinicalTrials.gov ID
- NCT03555721
- Acronym / sponsor ID
- HSC-GEN-17-1067
- Conditions
- Oral Cavity Cancer, Oropharyngeal Cancer
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: low subject recruitment
- Enrolment
- 18 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- M.D. Anderson Cancer Center
- Study start
- 30 May 2018 (actual)
- Primary completion
- 1 Nov 2022 (actual)
- Study completion
- 1 Nov 2022 (actual)
- First posted
- 13 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oral examination followed by biopsy, CytID, and hpvID | – | Other: Oral examination with incandescent light, Other: Oral examination with OralID, Diagnostic Test: Biopsy, Diagnostic Test: CytID, Diagnostic Test: hpvIDIdentification 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral examination with incandescent lightSuspicious oral lesions will be identified by oral examination with incandescent light. | Other | Oral examination followed by biopsy, CytID, and hpvID |
| Oral examination with OralIDOralID uses a proven, optically based fluorescence technology that provides the clinician an aid in visualization of oral cancer, pre-cancer and other abnormal lesions. | Other | Oral examination followed by biopsy, CytID, and hpvID |
| BiopsyTissue will be collected to identify pre-cancerous or cancerous cells | Diagnostic test | Oral examination followed by biopsy, CytID, and hpvID |
| CytIDCytID™ 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 | Oral examination followed by biopsy, CytID, and hpvID |
| hpvIDhpvID™ 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. | Diagnostic test | Oral examination followed by biopsy, CytID, and hpvID |
Primary outcome
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)
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)
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)
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)
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)
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)
Results and safety
The study was stopped early (reason given: low subject recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clifton M Nichols, DDS principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oral Cavity Cancer and Oropharyngeal Cancer, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: low subject recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2023.