NCT00502125

Brief Summary

The objective of this study is to evaluate the feasibility of using reflectance confocal imaging to noninvasively detect and diagnose oral dysplasia and early carcinoma.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2003

Longer than P75 for all trials

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

January 1, 2003

Completed
4.5 years until next milestone

First Submitted

Initial submission to the registry

July 13, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 17, 2007

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

August 1, 2012

Status Verified

July 1, 2012

Enrollment Period

6.7 years

First QC Date

July 13, 2007

Last Update Submit

July 31, 2012

Conditions

Oral Tumors

Keywords

Reflectance Confocal ImagingOral Mucosal LesionsOral Mucosa DiseaseNeoplasia Detection

Outcome Measures

Primary Outcomes (1)

  • To study if using reflectance confocal imaging can detect and diagnose abnormal growths in the mouth and early cancer.

    6 Years

Study Arms (1)

Patients with oral lesions

Procedure: Reflectance Confocal Imaging

Interventions

Reflectance Confocal ImagingPROCEDURE

A photograph will be taken of any abnormal areas inside the mouth. A small probe will expose the oral lining to a small amount of light. Some of this light will be reflected back into the probe, and be picked up by a computer. Pictures will be made of the tissue.

Patients with oral lesions

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with oral lesions.

You may qualify if:

  • Patients with oral lesions who give informed consent to participate in the study.
  • Any person with an oral lesion, particularly those suspicious for dysplasia or carcinoma.

You may not qualify if:

  • Lack of any oral mucosal lesions
  • Oral lesions not physically accessible for probe placement or biopsy
  • Unwillingness to tolerate probe placement, dilute acetic acid rinse or biopsy
  • Unwillingness to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

U.T.M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Tissue samples will be removed.

Study Officials

  • Ann M. Gillenwater, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 13, 2007

First Posted

July 17, 2007

Study Start

January 1, 2003

Primary Completion

September 1, 2009

Study Completion

September 1, 2009

Last Updated

August 1, 2012

Record last verified: 2012-07

Locations

US(1)