Oral Squamous Cell Carcinoma or Severe DysplasiaNCT02306967
Fluorescent Visualization in Early Oral Cancer
A study testing resection of oral cancer in people with Oral Squamous Cell Carcinoma or Severe Dysplasia, run by University of Calgary at 1 site in Canada.
Trial summary
Studies from Vancouver show that fluorescent visualization (FV) is a useful method of controlling surgical margins. This early finding will now be confirmed in a national randomized controlled trial. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oral Squamous Cell Carcinoma or Severe Dysplasia
- What is being tested?
- resection of oral cancer
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2011to Dec 2017
- 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
- biopsy proven invasive oral cancer or severe dysplasia / Cis
- invasive cancer must be T1 or T2
- no prior history of oral cancer / treatment of oral cancer
Who cannot join
- prior history of oral cancer
- unable to provide informed consent
- lesion not able to be completely visualized by FV
Trial locations and contacts
1 site in 1 country.
About this study
Studies from Vancouver show that fluorescent visualization (FV) is a useful method of controlling surgical margins. This early finding will now be confirmed in a national randomized controlled trial.
- Being tested
- resection of oral cancer
- Keywords
- oral cancer, oral dysplasia
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Mouth Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
resection of oral cancerProcedure or surgery
Oral cancer will be resected.
resection of oral cancerProcedure or surgery
Oral cancer will be resected
| Study group | Role | What they receive |
|---|---|---|
| Standard Resection | Active comparator | Oral resection will be guided by usual practice. This involves identifying the tumour with white light and then marking surgical margins and resection the primary cancer. Receives: Procedure: resection of oral cancer |
| FV Guided Resection | Experimental | The oral resection will be guided by fluorescent visualization (FV). Receives: Procedure: resection of oral cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
disease specific survival
disease specific 5 year survival
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2014 (estimated)
- Study startSep 2011
- Primary completionOct 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral Squamous Cell Carcinoma or Severe DysplasiaStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- Terry Fox Research Institute
- Responsible party
- Principal investigator, Joseph C. Dort, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02306967
- Sponsor's protocol ID
- UCENT004
- Status last verified
- May 2018
- First submitted
- 1 Dec 2014
- Last updated
- 2 May 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fluorescent Visualization in Early Oral Cancer
- ClinicalTrials.gov ID
- NCT02306967
- Acronym / sponsor ID
- UCENT004
- Keywords
- oral cancer, oral dysplasia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- Terry Fox Research Institute
- Study start
- Sep 2011 (actual)
- Primary completion
- Oct 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 3 Dec 2014 (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.
Studies from Vancouver show that fluorescent visualization (FV) is a useful method of controlling surgical margins. This early finding will now be confirmed in a national randomized controlled trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Resection | Active comparator | Procedure: resection of oral cancerOral resection will be guided by usual practice. This involves identifying the tumour with white light and then marking surgical margins and resection the primary cancer. |
| FV Guided Resection | Experimental | Procedure: resection of oral cancerThe oral resection will be guided by fluorescent visualization (FV). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- biopsy proven invasive oral cancer or severe dysplasia / Cis
- invasive cancer must be T1 or T2
- no prior history of oral cancer / treatment of oral cancer
Key exclusion criteria (3 listed)
- prior history of oral cancer
- unable to provide informed consent
- lesion not able to be completely visualized by FV
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 |
|---|---|---|
| resection of oral cancerOral cancer will be resected. | Procedure or surgery | FV Guided Resection, Standard Resection |
| resection of oral cancerOral cancer will be resected | Procedure or surgery | FV Guided Resection, Standard Resection |
Primary outcome
disease specific survival
Time frame: 5 years
disease specific 5 year survival
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 2 May 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing resection of oral cancer in people with Oral Squamous Cell Carcinoma or Severe Dysplasia, run by University of Calgary at 1 site in Canada.
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 3 inclusion and 3 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 2 May 2018. 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 Canada. 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?
disease specific survival (time frame: 5 years). 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 2 May 2018.