Diagnostic Aids for Detection and Diagnosis of Oral Cancer

April 25, 2017 updated by: M.D. Anderson Cancer Center

Evaluation of Diagnostic Aids for Detection and Diagnosis of Oral Cancer

The goal of this clinical study is to find out if certain instruments/devices, such as wide field fluorescence imaging point spectroscopy and/or brush cytology, can help health care providers find mouth cancer more quickly than a standard oral clinical exam.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Study Procedures:

Certain types of light may cause cells to give off a tiny amount of light (called fluorescence). Researchers have learned that cancer cells and normal cells reflect light and give off fluorescence differently. Researchers want to find out if different kinds of light can be used to discover areas of the mouth that may have abnormal or cancerous cells.

If you agree to take part in this study, a researcher may use up to 3 types of imaging instruments to take pictures and readings of several areas in your mouth.

  • VELScope is an FDA approved handheld camera device that takes images of the mouth with different colors of light. The VELScope shines blue light into the mouth, and pictures are taken using a camera that is attached to the device.
  • Widefield Fluorescence Imaging uses a non-contact imaging device similar to the VELScope. It shines different colors of light and then takes pictures of the inside of the mouth using a digital camera.
  • Point Spectroscopy System uses a probe (about the size of a tip of a pen) that is gently placed on several areas of the mouth. Different colors of light are directed through optic fibers to the lining of the mouth, and the probe collects the light that returns from the tissue and sends the information to a computer.

Researchers will record whether the doctors find any areas within your mouth that may not appear completely normal. They will collect tissue samples of these abnormal areas using a brush biopsy. To perform an oral brush biopsy, the research will press a small brush against an area inside your mouth, and turn it 5-10 times. The areas that could be biopsied include your gums, tongue, the roof of your mouth, the bottom of your mouth, or the inside of your cheeks. Any cells collected from the inside of your mouth will be placed on slides to be studied by the study team.

The samples being collected will only be used for this testing, and no leftover samples will be kept by the research staff.

These procedures should take about 20 minutes total.

This is an investigational study. The VELScope is an FDA approved device and is commercially available. Wide-field and point spectroscopy systems are not FDA approved and are only authorized for research. Up to 500 participants will take part in this multicenter study. Up to 250 will be enrolled at MD Anderson.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Subjects 18 years and older who are willing to participate.
  2. Persons presenting for: Physical or dental exams at outside health care centers OR Research meetings/gatherings OR Subjects identified at MDACC who are not already diagnosed with oral cancer or pre oral cancer: this includes patients with malignancies other than oral cancer, and visitors and family members, attendees of the HNS Oral Cancer Screening event who are willing to participate.

Exclusion Criteria:

  1. Subjects with a current diagnosis of oral cancer.
  2. Subjects under the age of 18. It is extremely unusual for children to develop oral cancer, therefore data from persons younger than 18 may add unexpected variables which could affect data analysis.
  3. Subjects who are unable or unwilling to give informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Oral Imaging and Cytology
Participant completes a short questionnaire regarding their awareness of oral cancer and risk factors. Oral cavity inspected using a standard white light headlamp. Oral cavity then examined with one or more of the widefield imaging devices, such as the VELscope and/or PS2 device. Exfoliative cells for cytology from an abnormal area (if present) and from a contralateral normal appearing area obtained using a brush.
Behavioral: Questionnaire
Participant completes a short questionnaire regarding their awareness of oral cancer and risk factors.
Other Names:
  • Survey
Device: POS + PS2 + VELscope
Oral cavity examined with one or more of the widefield imaging devices, such as the VELscope and/or PS2 device.
Procedure: Oral Brush Biopsy
If abnormal areas found, a small brush is pressed against an area inside mouth, and turned 5-10 times. The areas that could be biopsied include gums, tongue, roof of mouth, bottom of mouth, or the inside of cheeks.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Performance of the POS, PS2 and VELscope as Diagnostic Aid for Oral Cancer
Time Frame: 1 day
Information obtained from the fluorescence and reflectance images, point spectroscopy, and oral cytology compared with clinical diagnosis to evaluate the performance of the diagnostic aids and assess any clinical benefit to assist in screening for oral cancer. ROC curve analysis used as primary method for evaluating the performance of the POS, PS2 and VELscope devices as compared to the white light standard clinical diagnosis.
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
M.D. Anderson Cancer Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institutes of Health (NIH)
William Marsh Rice University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ann M. Gillenwater, MD, BA, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2014

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 23, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 25, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 29, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 27, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 25, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2012-0887
  • NCI-2014-02105 (Registry Identifier: NCI CTRP)
  • RO1 910576 (Other Grant/Funding Number: NCI)
  • 960113 (Other Grant/Funding Number: CPRIT)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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