Oral CancerPhase 1PolProbeNCT01604759
Polarized Reflectance Spectroscopy for Oral Lesions
A Phase 1 study testing Polarized Reflectance Spectroscopy System in people with Oral Cancer, run by British Columbia Cancer Agency at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oral Cancer
- What is being tested?
- Polarized Reflectance Spectroscopy System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2011to Dec 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- You are under the age of 18 years.
Trial locations and contacts
1 site in 1 country.
Canada1 site
British Columbia Cancer Agency - Vancouver Centre
Vancouver, British Columbia, V5Z 1L3
About this study
Official title: Evaluation of Polarized Reflectance Spectroscopy for Detection of High-risk Oral Lesions
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.
Read more
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.
Read the 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.
- Conditions
- Oral Cancer
- Being tested
- Polarized Reflectance Spectroscopy System
- Keywords
- Mouth Neoplasms, Mouth Diseases
- Medical subject headings
- Mouth Neoplasms, Mouth Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polarized Reflectance Spectroscopy SystemDevice
Also called Polarized Reflectance Spectroscopy System., Research device developed at MD Anderson Cancer Centre, Dept of Imaging Physics specifically for this study.
Fiber optic probe designed to measure polarized reflectance spectroscopy will be used to gather data from all study participants.
| Study group | Role | What they receive |
|---|---|---|
| Polarized probe measurement. | Other | 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. Receives: Device: Polarized Reflectance Spectroscopy System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2012 (estimated)
- Study startDec 2011
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- British Columbia Cancer Agency
- Sponsor type
- University, hospital or other
- Collaborators
- M.D. Anderson Cancer Center, University of Texas at Austin
- Responsible party
- Sponsor
- Investigators
- Catherine Poh, M.D. Ph.D, Principal investigator, British Columbia Cancer Agency
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01604759
- Sponsor's protocol ID
- H10-01313
- Other IDs
- 5RO1EB00354004 (PC-1)
- Acronym
- PolProbe
- Status last verified
- Jan 2017
- First submitted
- 3 Nov 2010
- Last updated
- 31 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Polarized Reflectance Spectroscopy for Detection of High-risk Oral Lesions
- ClinicalTrials.gov ID
- NCT01604759
- Acronym / sponsor ID
- PolProbe / H10-01313
- Conditions
- Oral Cancer
- Keywords
- Mouth Neoplasms, Mouth Diseases
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- British Columbia Cancer AgencyUniversity, hospital or other
- Collaborators
- M.D. Anderson Cancer Center, University of Texas at Austin
- Study start
- Dec 2011
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 24 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Polarized probe measurement. | Other | Device: Polarized Reflectance Spectroscopy SystemAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- You are under the age of 18 years.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Polarized Reflectance Spectroscopy SystemAlso: Polarized Reflectance Spectroscopy System., Research device developed at MD Anderson Cancer Centre, Dept of Imaging Physics specifically for this study.Fiber optic probe designed to measure polarized reflectance spectroscopy will be used to gather data from all study participants. | Device | Polarized probe measurement. |
Primary outcome
To use the spectroscopic data collected to create a model for normal, dysplastic and cancerous tissue.
Time frame: 2 years
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Catherine Poh, M.D. Ph.D principal investigator
British Columbia Cancer Agency
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Polarized Reflectance Spectroscopy System in people with Oral Cancer, run by British Columbia Cancer Agency at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To use the spectroscopic data collected to create a model for normal, dysplastic and cancerous tissue. (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2017.