MedTrace Logo

Diagnostic Aids for Detection and Diagnosis of Oral Cancer

NCT02251639 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2017-04-27

No results posted yet for this study

Summary

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.

Conditions

Interventions

BEHAVIORAL

Questionnaire

Participant completes a short questionnaire regarding their awareness of oral cancer and risk factors.

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.

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • William Marsh Rice University

    collaborator OTHER

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Ann M. Gillenwater, MD, BA · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2020-10-31
Completion
2020-10-31
FDA Device
Yes

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02251639 on ClinicalTrials.gov