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Fluorescent Visualization in Early Oral Cancer

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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

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.

Condition or disease Intervention/treatment Phase
Oral Squamous Cell Carcinoma or Severe Dysplasia Procedure: resection of oral cancer Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Actual Study Start Date : September 2011
Actual Primary Completion Date : October 2017
Actual Study Completion Date : December 2017


Arm Intervention/treatment
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.
Procedure: resection of oral cancer
Oral cancer will be resected.

Procedure: resection of oral cancer
Oral cancer will be resected

Experimental: FV Guided Resection
The oral resection will be guided by fluorescent visualization (FV).
Procedure: resection of oral cancer
Oral cancer will be resected.

Procedure: resection of oral cancer
Oral cancer will be resected




Primary Outcome Measures :
  1. disease specific survival [ Time Frame: 5 years ]
    disease specific 5 year survival



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02306967


Locations
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Canada, Alberta
Foothills Hospital
Calgary, Alberta, Canada, T2N 4N1
Sponsors and Collaborators
University of Calgary
Terry Fox Research Institute

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Responsible Party: Joseph C. Dort, Professor of Surgery, University of Calgary
ClinicalTrials.gov Identifier: NCT02306967     History of Changes
Other Study ID Numbers: UCENT004
First Posted: December 3, 2014    Key Record Dates
Last Update Posted: May 2, 2018
Last Verified: May 2018

Keywords provided by Joseph C. Dort, University of Calgary:
oral cancer
oral dysplasia

Additional relevant MeSH terms:
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Carcinoma, Squamous Cell
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell