NCT00507182

Brief Summary

The goal of this clinical research study is to test a new way to look for cancer and pre-cancerous tissue changes inside the mouth.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
381

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 1999

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

July 2, 1999

Completed
8.1 years until next milestone

First Submitted

Initial submission to the registry

July 24, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 26, 2007

Completed
10.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 12, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 12, 2018

Completed
Last Updated

January 19, 2018

Status Verified

January 1, 2018

Enrollment Period

18.5 years

First QC Date

July 24, 2007

Last Update Submit

January 17, 2018

Conditions

Oral Cancer

Keywords

Oral Mucosa LesionsOral CancerNeoplasia and Dysplasia in oral cavity mucosaFluorescence SpectroscopyReflectance SpectroscopyPre-cancerous lesionsCancerous lesionsMouth

Outcome Measures

Primary Outcomes (1)

  • Classification of Oral Lesions

    Distinguishing between normal and abnormal sites with four lesion classifications of normal, non-malignant inflammatory, dysplasia, and neoplasia.

    11 Years

Study Arms (1)

Fluorescence Spectroscopy

EXPERIMENTAL

1-5 lesions + several normal-looking areas inside the mouth exposed to a beam of light; exposed tissues will emit very small amounts of fluorescence (light) then will be removed.

Procedure: Fluorescence Spectroscopy

Interventions

Fluorescence SpectroscopyPROCEDURE

1-5 lesions + several normal-looking areas inside the mouth exposed to a beam of light; exposed tissues will emit very small amounts of fluorescence (light) then will be removed.

Fluorescence Spectroscopy

Eligibility Criteria

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

You may qualify if:

  • \. Any person 18 years of age or older with a lesion of the oral mucosa. Persons with changes in existing lesions or those who develop new lesions can be re-evaluated, but it is not required.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Mouth NeoplasmsNeoplasms

Interventions

Spectrometry, Fluorescence

Condition Hierarchy (Ancestors)

Head and Neck NeoplasmsNeoplasms by SiteMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

FluorometryLuminescent MeasurementsPhotometryChemistry Techniques, AnalyticalInvestigative TechniquesSpectrum Analysis

Study Officials

  • Ann M. Gillenwater, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 24, 2007

First Posted

July 26, 2007

Study Start

July 2, 1999

Primary Completion

January 12, 2018

Study Completion

January 12, 2018

Last Updated

January 19, 2018

Record last verified: 2018-01

Locations

US(1)