Lip and Oral Cavity Squamous Cell CarcinomaNCT01816841
Direct Visual Fluorescence in Finding Oral Cancer in High-Risk Patients and Patients Undergoing Routine Dental Care
A study testing fluorescence imaging, biopsy and examination in people with Lip and Oral Cavity Squamous Cell Carcinoma and Oral Cavity Verrucous Carcinoma, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
Trial summary
This clinical trial studies direct visual fluorescence in finding oral cancer in high-risk patients and patients undergoing routine dental care. Diagnostic procedures, such as direct visual fluorescence, may help find and diagnose oral cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lip and Oral Cavity Squamous Cell Carcinoma, Oral Cavity Verrucous Carcinoma, Stage 0 Lip and Oral Cavity Cancer
- What is being tested?
- fluorescence imaging, biopsy and examination
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Nov 2008to 28 Dec 2019
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HIGH-RISK POPULATION:
- 33 consecutive consenting patients presenting to The Ohio State University James Cancer Hospital Otolaryngology Department with a suspicious oral lesion or prior biopsy-confirmed epithelial dysplasia (mild, moderate, severe), carcinoma in situ (CIS), or squamous cell carcinoma (SCC) will be recruited; adult patients presenting for initial evaluation for treatment planning and/or presenting for follow-up appointments monitoring for recurrence will be eligible to participate
- GENERAL POPULATION:
- 250 consecutive consenting patients presenting to The Ohio State University College of Dentistry for routing dental care will be recruited; adult patients presenting to the screening clinic for initial oral evaluation will be eligible to participate
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
Columbus, Ohio, 43210
About this study
Official title: The Role of Direct Visual Fluorescence in Oral Examination
This clinical trial studies direct visual fluorescence in finding oral cancer in high-risk patients and patients undergoing routine dental care. Diagnostic procedures, such as direct visual fluorescence, may help find and diagnose oral cancer.
Read the detailed description
PRIMARY OBJECTIVES:
- To assess the diagnostic benefit of the VELscope (direct visual fluorescence) inspection in oral examination.
II. Efficacy of the VELscope in identifying dysplastic (premalignant) and malignant oral mucosal lesions and in discriminating these lesions from common benign tissue changes.
III. Accuracy of clinical judgment versus VELscope findings. IV. Ability of the VELscope to identify lesions or extent of lesions beyond what is clinically apparent.
OUTLINE:
Patients undergo conventional oral examination (COE) followed by direct visual fluorescence examination (DVFE). Patients with tissue abnormalities found by COE or DVFE undergo scalpel biopsy within 2 weeks.
- Conditions
- Lip and Oral Cavity Squamous Cell Carcinoma, Oral Cavity Verrucous Carcinoma, Stage 0 Lip and Oral Cavity Cancer, Tongue Cancer
- Being tested
- fluorescence imaging, biopsy, examination, Comparison of surgical margins by COE vs. DVFE
- Keywords
- Direct Visual Fluorescense, Oral Examination, oral cancer
- Medical subject headings
- Lymphoid Interstitial Pneumonia, Squamous Cell Carcinoma of Head and Neck, Mouth Neoplasms, Tongue Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fluorescence imagingProcedure or surgery
Undergo DVFE
biopsyProcedure or surgery
Also called biopsies
Undergo scalpel biopsy
examinationProcedure or surgery
Also called Exam, Medical Assessment, Medical Exam, Medical Examination
Undergo COE
Comparison of surgical margins by COE vs. DVFEProcedure or surgery
Surgical margin determination using DVFE
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic (COE and DVFE)- Arm I | Experimental | Arm I - Patients undergo COE followed by DVFE. Patients with tissue abnormalities found by COE or DVFE undergo biopsy within 2 weeks. Receives: Procedure: fluorescence imaging; Procedure: biopsy; Procedure: examination |
| Arm II - Comparison of surgical margins using COE vs. DVFE | Experimental | Comparison of surgical margins using COE vs. DVFE Receives: Procedure: fluorescence imaging; Procedure: biopsy; Procedure: examination; Procedure: Comparison of surgical margins by COE vs. DVFE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity of DVFE compared to visual inspection by conventional oral examination alone
Will be evaluated by calculating sensitivity and specificity and their corresponding exact 95% confidence intervals. Association between the two techniques will be assessed using the simple kappa statistic.
Measured: At the time of examination
Differences between lesional margins identified by COE and DVFE
Will be evaluated using the dependent t-test. In the event that the parametric requirements of this test are not met, the Wilcoxon, matched-pairs, signed-ranks test will be used.
Measured: At the time of examination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2013 (estimated)
- Study start11 Nov 2008
- Primary completion3 Oct 2016
- Study completion28 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lip and Oral Cavity Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Ohio State University Comprehensive Cancer CenterThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kristin McNamara, Ohio State University Comprehensive Cancer Center
- Investigators
- Kristin McNamara, DDS, MS, Principal investigator, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01816841
- Sponsor's protocol ID
- OSU-08095
- Other IDs
- NCI-2012-02017
- Status last verified
- Jan 2020
- First submitted
- 20 Mar 2013
- Last updated
- 30 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Direct Visual Fluorescence in Oral Examination
- ClinicalTrials.gov ID
- NCT01816841
- Acronym / sponsor ID
- OSU-08095
- Conditions
- Lip and Oral Cavity Squamous Cell Carcinoma, Oral Cavity Verrucous Carcinoma, Stage 0 Lip and Oral Cavity Cancer, Tongue Cancer
- Keywords
- Direct Visual Fluorescense, Oral Examination, oral cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 11 Nov 2008 (actual)
- Primary completion
- 3 Oct 2016 (actual)
- Study completion
- 28 Dec 2019 (actual)
- First posted
- 22 Mar 2013 (estimated)
- 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.
This clinical trial studies direct visual fluorescence in finding oral cancer in high-risk patients and patients undergoing routine dental care. Diagnostic procedures, such as direct visual fluorescence, may help find and diagnose oral cancer.
Detailed description
PRIMARY OBJECTIVES:
- To assess the diagnostic benefit of the VELscope (direct visual fluorescence) inspection in oral examination.
II. Efficacy of the VELscope in identifying dysplastic (premalignant) and malignant oral mucosal lesions and in discriminating these lesions from common benign tissue changes.
III. Accuracy of clinical judgment versus VELscope findings. IV. Ability of the VELscope to identify lesions or extent of lesions beyond what is clinically apparent.
OUTLINE:
Patients undergo conventional oral examination (COE) followed by direct visual fluorescence examination (DVFE). Patients with tissue abnormalities found by COE or DVFE undergo scalpel biopsy within 2 weeks.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diagnostic (COE and DVFE)- Arm I | Experimental | Procedure: fluorescence imaging, Procedure: biopsy, Procedure: examinationArm I - Patients undergo COE followed by DVFE. Patients with tissue abnormalities found by COE or DVFE undergo biopsy within 2 weeks. |
| Arm II - Comparison of surgical margins using COE vs. DVFE | Experimental | Procedure: fluorescence imaging, Procedure: biopsy, Procedure: examination, Procedure: Comparison of surgical margins by COE vs. DVFEComparison of surgical margins using COE vs. DVFE |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- HIGH-RISK POPULATION:
- 33 consecutive consenting patients presenting to The Ohio State University James Cancer Hospital Otolaryngology Department with a suspicious oral lesion or prior biopsy-confirmed epithelial dysplasia (mild, moderate, severe), carcinoma in situ (CIS), or squamous cell carcinoma (SCC) will be recruited; adult patients presenting for initial evaluation for treatment planning and/or presenting for follow-up appointments monitoring for recurrence will be eligible to participate
- GENERAL POPULATION:
- 250 consecutive consenting patients presenting to The Ohio State University College of Dentistry for routing dental care will be recruited; adult patients presenting to the screening clinic for initial oral evaluation will be eligible to participate
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| fluorescence imagingUndergo DVFE | Procedure or surgery | Arm II - Comparison of surgical margins using COE vs. DVFE, Diagnostic (COE and DVFE)- Arm I |
| biopsyAlso: biopsiesUndergo scalpel biopsy | Procedure or surgery | Arm II - Comparison of surgical margins using COE vs. DVFE, Diagnostic (COE and DVFE)- Arm I |
| examinationAlso: Exam, Medical Assessment, Medical Exam, Medical ExaminationUndergo COE | Procedure or surgery | Arm II - Comparison of surgical margins using COE vs. DVFE, Diagnostic (COE and DVFE)- Arm I |
| Comparison of surgical margins by COE vs. DVFESurgical margin determination using DVFE | Procedure or surgery | Arm II - Comparison of surgical margins using COE vs. DVFE |
Primary outcome
Sensitivity and specificity of DVFE compared to visual inspection by conventional oral examination alone
Time frame: At the time of examination
Will be evaluated by calculating sensitivity and specificity and their corresponding exact 95% confidence intervals. Association between the two techniques will be assessed using the simple kappa statistic.
Differences between lesional margins identified by COE and DVFE
Time frame: At the time of examination
Will be evaluated using the dependent t-test. In the event that the parametric requirements of this test are not met, the Wilcoxon, matched-pairs, signed-ranks test will be used.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2020.
- The JameslineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Kristin McNamara, DDS, MS principal investigator
Ohio State University Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fluorescence imaging, biopsy and examination in people with Lip and Oral Cavity Squamous Cell Carcinoma and Oral Cavity Verrucous Carcinoma, run by Ohio State University Comprehensive Cancer Center 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 4 inclusion and 0 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: finished, as of the sponsor's last update on 30 Jan 2020. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Sensitivity and specificity of DVFE compared to visual inspection by conventional oral examination alone (time frame: At the time of examination). The study lists 2 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 30 Jan 2020.