Oral Squamous Cell Carcinoma or Severe Dysplasia
Conditions
Keywords
oral cancer, oral dysplasia
Brief 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.
Interventions
PROCEDUREresection of oral cancer
Oral cancer will be resected.
Sponsors
Terry Fox Research Institute
University of Calgary
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| disease specific survival | 5 years | disease specific 5 year survival |
Countries
Canada
Outcome results
None listed