Biopsy for Oral Disorder

M D Anderson Cancer Center, Houston, TX
Oral Disorder+3 More ConditionsBiopsy - Procedure
All Sexes

Study Summary

This trial uses new types of imaging devices to see if they can help doctors better determine if mouth lesions are pre-cancerous or cancerous.

Eligible Conditions
  • Oral Disorder
  • Premalignant Lesion
  • Oral Cancer
  • Dysplasia

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase < 1

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: Up to 2 years

Up to 2 years
Biomarker analysis
Cytologic results
Diagnostic assessment

Trial Safety

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

1 Treatment Group

Diagnostic (multimodal imaging, biopsy)
1 of 1

Experimental Treatment

600 Total Participants · 1 Treatment Group

Primary Treatment: Biopsy · No Placebo Group · Phase < 1

Diagnostic (multimodal imaging, biopsy)Experimental Group · 4 Interventions: Biopsy, Fluorescence Imaging, High-Resolution Microendoscopy, Proflavine Hemisulfate · Intervention Types: Procedure, Procedure, Procedure, Drug
First Studied
Drug Approval Stage
How many patients have taken this drug
Completed Phase 4
Fluorescence Imaging
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 2 years

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,849 Previous Clinical Trials
1,793,044 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,283 Previous Clinical Trials
41,234,798 Total Patients Enrolled
Ann GillenwaterPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
275 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 0 Total Inclusion Criteria

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Frequently Asked Questions

How many participants are included in the research project?

"Affirmative. According to the website, recruitment for this trial is ongoing; it was first published on May 25th 2016 and last modified on October 12th 2022. There are 600 slots available at 1 medical facility." - Anonymous Online Contributor

Unverified Answer

Has High-Resolution Microendoscopy been a subject of any other research projects?

"Currently, there are 3 clinical trials in progress that research High-Resolution Microendoscopy and none of them have reached Phase 3. Primarily based in Houston, Texas these investigations into this medical technique span across three distinct locations." - Anonymous Online Contributor

Unverified Answer

Does this experiment currently require the participation of new trial participants?

"Per, enrollment for this trial is open to the public. The study was initially published on May 25th 2016 and was recently updated on October 12th 2022." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.