Spectroscopy for Diagnostic Assessment of Oral Mucosal Le... | NCT00507182

Studies
Spectroscopy for Diagnostic Assessment of Oral Mucosal Lesions

NCT00507182

Sponsor

M.D. Anderson Cancer Center

Status

Completed

Last Update Posted

Jan 19, 2018Actual

Enrollment

381Actual

Phase

Not Applicable

Conditions

Oral Cancer

Interventions

Fluorescence Spectroscopy

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
NCI-2012-01601	Registry Identifier	NCI CTRP

Status Module

Record Verification Date

Jan 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2, 1999Actual

Primary Completion Date

Jan 12, 2018Actual

Completion Date

Jan 12, 2018Actual

First Submitted Date

Jul 24, 2007

First Submission Date that Met QC Criteria

Jul 25, 2007

First Posted Date

Jul 26, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 17, 2018

Last Update Posted Date

Jan 19, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Abnormal-looking areas (lesions) inside the mouth may be a sign of cancer or changes that may lead to cancer. These lesions may need to be removed. Researchers are looking for a practical way to tell early on whether these lesions are cancer or may become cancer. This study will test a technique called fluorescence spectroscopy, which is under research in this study.

Each patient may have 1 to 5 lesions and several normal-looking areas inside the mouth exposed to a beam of light. The exposed tissues may emit very small amounts of light called fluorescence. This light is not seen by the eye but is detected by a computer. The small areas exposed to the light beam may then be removed.

The patients who need surgery may have the small tested areas removed when the lesions are surgically removed. A small sample from a normal-looking area may also be removed during surgery. Patients who do not need surgery may simply have small samples taken from the lesions and a normal-looking area in the clinic rather than in the operating room. The tissues will be looked at under a microscope to see whether they are cancerous. These results will be compared with the spectroscopy results.

If you are scheduled to participate in another MD Anderson study, Protocol 2008-0137 Entitled, "Phase Ib Study of Erlotinib Prior to Surgery in Patients with Head and Neck Cancer" (Study Chair: Dr. William William), some of your collected tissue samples may be shared with Dr. William for use on 2008-0137.

This is an investigational study. About 395 patients will be consented and screened for this study, with about 381 to take full part in this study. All will be treated at MD Anderson.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

381Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Fluorescence Spectroscopy	Procedure	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Classification of Oral Lesions	Distinguishing between normal and abnormal sites with four lesion classifications of normal, non-malignant inflammatory, dysplasia, and neoplasia.	11 Years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

1. 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.

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ann M. Gillenwater, MD	M.D. Anderson Cancer Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Texas MD Anderson Cancer Center		Houston	Texas	77030	United States

References Module

Citations

Not provided

ID	Term
D009062	Mouth Neoplasms
D009369	Neoplasms

ID	Term
D006258	Head and Neck Neoplasms
D009371	Neoplasms by Site
D009059	Mouth Diseases
D009057	Stomatognathic Diseases

ID	Term
D005470	Fluorometry
D008163	Luminescent Measurements
D010783	Photometry
D002623	Chemistry Techniques, Analytical