Oral Squamous Cell Carcinoma or Severe Dysplasia Clinical Trial
| NCT number | NCT02306967 |
| Other study ID # | UCENT004 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | September 2011 |
| Est. completion date | December 2017 |
| Verified date | May 2018 |
| Source | University of Calgary |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 40 |
| Est. completion date | December 2017 |
| Est. primary completion date | October 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Canada | Foothills Hospital | Calgary | Alberta |
| Lead Sponsor | Collaborator |
|---|---|
| University of Calgary | Terry Fox Research Institute |
Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | disease specific survival | disease specific 5 year survival | 5 years |