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Fluorescent Visualization in Early Oral Cancer

Primary Purpose

Oral Squamous Cell Carcinoma or Severe Dysplasia

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
resection of oral cancer
resection of oral cancer
Sponsored by
University of Calgary
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Oral Squamous Cell Carcinoma or Severe Dysplasia focused on measuring oral cancer, oral dysplasia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Foothills Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard Resection

FV Guided Resection

Arm Description

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.

The oral resection will be guided by fluorescent visualization (FV).

Outcomes

Primary Outcome Measures

disease specific survival
disease specific 5 year survival

Secondary Outcome Measures

Full Information

First Posted
December 1, 2014
Last Updated
May 1, 2018
Sponsor
University of Calgary
Collaborators
Terry Fox Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT02306967
Brief Title
Fluorescent Visualization in Early Oral Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
September 2011 (Actual)
Primary Completion Date
October 2017 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Calgary
Collaborators
Terry Fox Research Institute

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Squamous Cell Carcinoma or Severe Dysplasia
Keywords
oral cancer, oral dysplasia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard Resection
Arm Type
Active Comparator
Arm Description
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.
Arm Title
FV Guided Resection
Arm Type
Experimental
Arm Description
The oral resection will be guided by fluorescent visualization (FV).
Intervention Type
Procedure
Intervention Name(s)
resection of oral cancer
Intervention Description
Oral cancer will be resected.
Intervention Type
Procedure
Intervention Name(s)
resection of oral cancer
Intervention Description
Oral cancer will be resected
Primary Outcome Measure Information:
Title
disease specific survival
Description
disease specific 5 year survival
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Foothills Hospital
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N1
Country
Canada

12. IPD Sharing Statement

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Fluorescent Visualization in Early Oral Cancer

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