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Polarized Reflectance Spectroscopy for Oral Lesions (PolProbe)

Primary Purpose

Oral Cancer

Status
Completed
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Polarized Reflectance Spectroscopy System
Sponsored by
British Columbia Cancer Agency
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Oral Cancer focused on measuring Mouth Neoplasms, Mouth Diseases

Eligibility Criteria

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

Inclusion Criteria:

  • You attend the Dental Department at the British Columbia Cancer Agency
  • You have an abnormal lesion in the mouth
  • You fully understand the study and give your informed consent to participate as demonstrated by signing this consent form

Exclusion Criteria:

  • You are under the age of 18 years.

Sites / Locations

  • British Columbia Cancer Agency - Vancouver Centre

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Polarized probe measurement.

Arm Description

All patients belong under this arm as all will be measured by the polarized probe and the data will be compared to the biopsy site's pathology results.

Outcomes

Primary Outcome Measures

To use the spectroscopic data collected to create a model for normal, dysplastic and cancerous tissue.
The goals of the statistical analysis will be to determine an appropriate model for predicting whether the lesion is normal or abnormal (dysplasia or carcinoma) based on spectroscopic characteristics. The investigators will estimate sensitivity and specificity of the predictions made by the model and compare this to sensitivity and specificity of standard white light clinical examination currently used in clinical practice.

Secondary Outcome Measures

Full Information

First Posted
November 3, 2010
Last Updated
January 30, 2017
Sponsor
British Columbia Cancer Agency
Collaborators
M.D. Anderson Cancer Center, University of Texas at Austin
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1. Study Identification

Unique Protocol Identification Number
NCT01604759
Brief Title
Polarized Reflectance Spectroscopy for Oral Lesions
Acronym
PolProbe
Official Title
Evaluation of Polarized Reflectance Spectroscopy for Detection of High-risk Oral Lesions
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
British Columbia Cancer Agency
Collaborators
M.D. Anderson Cancer Center, University of Texas at Austin

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
In this study the investigators are conducting research to determine whether a new optical device using polarization reflectance spectroscopy can help doctors or dentists identify abnormalities in the mouth that require follow-up. To establish this, measurements are needed from a large number of individuals with different abnormalities in their mouth. The investigators believe the proposed approach has potential to improve and enable mass screening for precancerous and early cancers of the oral cavity by improving the predictive value of oral cavity exams, particularly for less experienced practitioners. The information from this study will be compared to results from the pathology report of the tissue taken from your mouth. Hypothesis: Polarized reflectance spectroscopy can distinguish high-risk oral lesion from normal and reactive oral lesions. Polarized reflectance spectroscopy can capture low-grade oral lesions that have characteristics associated with a high risk of progression to cancer.
Detailed Description
The clinician will place a fiber-optic probe designed to measure the polarized reflectance spectra over the visible optical region on a site of interest in the subject's mouth, including lesional mucosa, normal adjacent and contralateral mucosa. The site for placement of the probe will be determined by the examiner, an experienced Oral Pathologist. The probe examination will take no more than 15 minutes in addition to the subject's appointment time for their routine visits. A 4um unstained tissue section from surgery or biopsy, part of their scheduled care, will be requested for quantitative histological analysis. The morphometric parameters obtained from polarized reflectance measurements will be compared with the histology and quantitative pathology (nuclear phenotype score) from the tissue sections from the lesion. The collected spectra data from normal looking areas from adjacent normal looking mucosa and contralateral mucosa will be used to determine patient to patient variation in the polarized reflectance of oral mucosa.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Cancer
Keywords
Mouth Neoplasms, Mouth Diseases

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Polarized probe measurement.
Arm Type
Other
Arm Description
All patients belong under this arm as all will be measured by the polarized probe and the data will be compared to the biopsy site's pathology results.
Intervention Type
Device
Intervention Name(s)
Polarized Reflectance Spectroscopy System
Other Intervention Name(s)
Polarized Reflectance Spectroscopy System., Research device developed at MD Anderson Cancer Centre, Dept of Imaging Physics specifically for this study.
Intervention Description
Fiber optic probe designed to measure polarized reflectance spectroscopy will be used to gather data from all study participants.
Primary Outcome Measure Information:
Title
To use the spectroscopic data collected to create a model for normal, dysplastic and cancerous tissue.
Description
The goals of the statistical analysis will be to determine an appropriate model for predicting whether the lesion is normal or abnormal (dysplasia or carcinoma) based on spectroscopic characteristics. The investigators will estimate sensitivity and specificity of the predictions made by the model and compare this to sensitivity and specificity of standard white light clinical examination currently used in clinical practice.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: You attend the Dental Department at the British Columbia Cancer Agency You have an abnormal lesion in the mouth You fully understand the study and give your informed consent to participate as demonstrated by signing this consent form Exclusion Criteria: You are under the age of 18 years.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catherine Poh, M.D. Ph.D
Organizational Affiliation
British Columbia Cancer Agency
Official's Role
Principal Investigator
Facility Information:
Facility Name
British Columbia Cancer Agency - Vancouver Centre
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1L3
Country
Canada

12. IPD Sharing Statement

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Polarized Reflectance Spectroscopy for Oral Lesions

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