Fluorescent Visualization in Early Oral Cancer
This trial is active, not recruiting.
|Condition||oral squamous cell carcinoma or severe dysplasia|
|Treatments||resection of oral cancer|
|Sponsor||University of Calgary|
|Collaborator||Terry Fox Research Institute|
|Start date||September 2011|
|End date||October 2017|
|Trial size||40 participants|
|Trial identifier||NCT02306967, UCENT004|
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.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, caregiver, investigator, outcomes assessor)|
disease specific survival
time frame: 5 years
Male or female participants at least 18 years old.
Inclusion Criteria: - 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 Exclusion Criteria: - prior history of oral cancer - unable to provide informed consent - lesion not able to be completely visualized by FV
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