Diagnostic Procedure for Tobacco Dependence

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Tobacco Dependence+11 More
Diagnostic Procedure - Procedure
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is examining if using fluorescent imaging, spectroscopy, and tissue samples can help detect oral cancer earlier.

Eligible Conditions
  • Tobacco Dependence
  • Fanconi Anemia
  • Erythroplakia
  • Lichen Planus
  • Leukoplakia
  • Premalignant Lesion
  • Lip structure
  • Oral Neoplasm

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

3 Primary · 0 Secondary · Reporting Duration: Up to 10 years

Up to 10 years
Lesions diagnosed via non-invasive brush cytology
Lesions diagnosed via point spectroscopy system
Lesions diagnosed via wide-field fluorescence imaging

Trial Safety

Safety Progress

1 of 3

Trial Design

1 Treatment Group

Diagnostic (fluorescent/reflectance imaging, spectroscopy)
1 of 1
Experimental Treatment

338 Total Participants · 1 Treatment Group

Primary Treatment: Diagnostic Procedure · No Placebo Group · N/A

Diagnostic (fluorescent/reflectance imaging, spectroscopy)Experimental Group · 5 Interventions: Diagnostic Procedure, Diagnostic Microscopy, Fluorescence Spectroscopy, Fluorescence Imaging, Cytology Specimen Collection Procedure · Intervention Types: Procedure, Procedure, Procedure, Procedure, Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Diagnostic Microscopy
2017
Completed Early Phase 1
~50
Fluorescence Spectroscopy
1999
N/A
~390
Fluorescence Imaging
2014
N/A
~80

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 10 years

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,779 Previous Clinical Trials
1,784,425 Total Patients Enrolled
1 Trials studying Tobacco Dependence
839 Patients Enrolled for Tobacco Dependence
National Cancer Institute (NCI)NIH
12,990 Previous Clinical Trials
41,298,550 Total Patients Enrolled
10 Trials studying Tobacco Dependence
10,817 Patients Enrolled for Tobacco Dependence
Ann M GillenwaterPrincipal InvestigatorM.D. Anderson Cancer Center

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a history of head and neck cancer or oral premalignant disease but without any clinical evidence of disease.
You have any other condition that increases your risk for oral cancer development.
You have either pre-malignant or a history of oral cancer based on patient history and clinical presentations.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 27th, 2021

Last Reviewed: October 14th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.