RECRUITING

Precision Optical Guidance for Oral Biopsy

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

To learn if a new type of imaging device called the Active Biopsy Guidance System can help doctors to decide when and where to perform invasive biopsies of mouth lesions.

Official Title

Precision Optical Guidance for Oral Biopsy Based on Next-Generation Hallmarks of Cancer (1R01DE029590-01): A Clinical Study to Evaluate and Optimize the Technical Performance Characteristics of an Active Biopsy Guidance System

Quick Facts

Study Start:2023-06-15

Study Completion:2025-03-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05554133

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Adult subjects with clinically evident oral lesions such as leukoplakia or erythroplakia, oral potentially malignant disorders (OPMD) such as lichen planus and graft vs. host disease, pathologic diagnosis of dysplasia, squamous cell carcinoma, or a history of resected oral cancer, are eligible to participate. Patients with previous treatment including surgery, radiation, chemotherapy or other therapies are also eligible. 2. Ability to understand and willingness to sign a written Informed Consent Document (ICD).	1. Known allergy to proflavine or acriflavine. 2. Age less than 18 years. 3. Pregnant or nursing females. 4. Adults unable to consent 5. Prisoners and other vulnerable populations

Inclusion Criteria

Exclusion Criteria

1. Adult subjects with clinically evident oral lesions such as leukoplakia or erythroplakia, oral potentially malignant disorders (OPMD) such as lichen planus and graft vs. host disease, pathologic diagnosis of dysplasia, squamous cell carcinoma, or a history of resected oral cancer, are eligible to participate. Patients with previous treatment including surgery, radiation, chemotherapy or other therapies are also eligible.
2. Ability to understand and willingness to sign a written Informed Consent Document (ICD).

1. Known allergy to proflavine or acriflavine.
2. Age less than 18 years.
3. Pregnant or nursing females.
4. Adults unable to consent
5. Prisoners and other vulnerable populations

Contacts and Locations

Study Contact

Ann Gillenwater, MD

CONTACT

(713) 792-8841

agillenw@mdanderson.org

Principal Investigator

Ann Gillenwater, MD

PRINCIPAL_INVESTIGATOR

MD Anderson Caner Center

Study Locations (Sites)

M D Anderson Cancer Center

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: M.D. Anderson Cancer Center

Ann Gillenwater, MD, PRINCIPAL_INVESTIGATOR, MD Anderson Caner Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-06-15

Study Completion Date2025-03-31

Study Record Updates

Study Start Date2023-06-15

Study Completion Date2025-03-31

Terms related to this study

Additional Relevant MeSH Terms

Oral Lesions