NCT02251639

Brief 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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2014

Longer than P75 for phase_1 head-and-neck-cancer

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 23, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 29, 2014

Completed
2 days until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
Last Updated

April 27, 2017

Status Verified

April 1, 2017

Enrollment Period

6 years

First QC Date

September 23, 2014

Last Update Submit

April 25, 2017

Conditions

Head and Neck Cancer

Keywords

Oral cancerPre-cancerWidefield Fluorescence ImagingVELScopePoint Spectroscopy SystemOral brush biopsyQuestionnaireSurveyDiagnostic aidScreening

Outcome Measures

Primary Outcomes (1)

  • Performance of the POS, PS2 and VELscope as Diagnostic Aid for Oral Cancer

    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

Study Arms (1)

Oral Imaging and Cytology

EXPERIMENTAL

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: QuestionnaireDevice: POS + PS2 + VELscopeProcedure: Oral Brush Biopsy

Interventions

QuestionnaireBEHAVIORAL

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

Also known as: Survey
Oral Imaging and Cytology
POS + PS2 + VELscopeDEVICE

Oral cavity examined with one or more of the widefield imaging devices, such as the VELscope and/or PS2 device.

Oral Imaging and Cytology
Oral Brush BiopsyPROCEDURE

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.

Oral Imaging and Cytology

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects 18 years and older who are willing to participate.
  • 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.

You may not qualify if:

  • Subjects with a current diagnosis of oral cancer.
  • 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.
  • Subjects who are unable or unwilling to give informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Head and Neck NeoplasmsMouth Neoplasms

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Ann M. Gillenwater, MD, BA

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2014

First Posted

September 29, 2014

Study Start

October 1, 2014

Primary Completion

October 1, 2020

Study Completion

October 1, 2020

Last Updated

April 27, 2017

Record last verified: 2017-04