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Fluorescent Visualization in Early Oral Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02306967
Recruitment Status : Completed
First Posted : December 3, 2014
Last Update Posted : May 2, 2018
Sponsor:
Collaborator:
Terry Fox Research Institute
Information provided by (Responsible Party):
Joseph C. Dort, University of Calgary

Tracking Information
First Submitted Date  ICMJE December 1, 2014
First Posted Date  ICMJE December 3, 2014
Last Update Posted Date May 2, 2018
Actual Study Start Date  ICMJE September 2011
Actual Primary Completion Date October 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 1, 2014)
disease specific survival [ Time Frame: 5 years ]
disease specific 5 year survival
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Fluorescent Visualization in Early Oral Cancer
Official Title  ICMJE Not Provided
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Oral Squamous Cell Carcinoma or Severe Dysplasia
Intervention  ICMJE
  • Procedure: resection of oral cancer
    Oral cancer will be resected.
  • Procedure: resection of oral cancer
    Oral cancer will be resected
Study Arms  ICMJE
  • Active Comparator: Standard Resection
    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.
    Interventions:
    • Procedure: resection of oral cancer
    • Procedure: resection of oral cancer
  • Experimental: FV Guided Resection
    The oral resection will be guided by fluorescent visualization (FV).
    Interventions:
    • Procedure: resection of oral cancer
    • Procedure: resection of oral cancer
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 17, 2016)
40
Original Estimated Enrollment  ICMJE
 (submitted: December 1, 2014)
60
Actual Study Completion Date  ICMJE December 2017
Actual Primary Completion Date October 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02306967
Other Study ID Numbers  ICMJE UCENT004
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Joseph C. Dort, University of Calgary
Study Sponsor  ICMJE University of Calgary
Collaborators  ICMJE Terry Fox Research Institute
Investigators  ICMJE Not Provided
PRS Account University of Calgary
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP