Evaluation of Two Non-Invasive Methods, High-Resolution Microendoscopy and Liquid-Based Cytology, for Detection of Oral Precancer

NCT07260344 | Recruiting

• 1 other identifier: DCEG-SRP-2025-001
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

Cancers of the oral cavity (lip, oral tongue, gingivae, floor of mouth, hard palate, and other mouth tissues including buccal mucosa) are amongst the most common worldwide, with an estimated annual burden of over 300,000 incident cases. Most oral cancers (\>75%) are attributable to cigarette smoking, alcohol drinking, and chewing of areca nut/betel quid with or without tobacco, and very few are related to human papillomavirus infection. Oral cancer incidence geographically tracks with the prevalence of these risk factors and is notably high in the Indian subcontinent (due to tobacco chewing and smoking) and southeast Asia (due to betel quid chewing without tobacco and smoking). The current standard for screening for oral precancer/cancer is visual and tactile examination by an expert for the presence of clinical/visual lesions (leukoplakia, erythroplakia, and oral submucous fibrosis). Such visually identified lesions are further triaged based on clinical impression for a biopsy to determine histopathologic presence/grade of dysplasia. Several observations point to key limitations of oral cancer screening based on clinical impression-based biopsy of visually identified lesions, including the decision to biopsy a lesion, which lesion to biopsy, and where within the lesion to direct a biopsy. Thus, there is a need for tools for improved triage of visual precancers for biopsy and targeting areas for biopsy within a lesion for more effective risk stratification and better provision of care. Two non-invasive methods hold promise for triage of lesions for biopsy-oral liquid-based cytology and high-resolution microendoscopy (HRME). Oral cytology provides a method to non-invasively sample visible oral lesions and holds promise to enable triage of lesions for biopsy. HRME utilizes optical fiber-based imaging in combination with the fluorescent contrast agent proflavine to image sub-cellular features in vivo in lesions/epithelial tissues, functionally an in situ biopsy. The investigators propose to conduct a cross-sectional study to evaluate the clinical utility of these two non-invasive methods for detecting oral precancer and early oral cavity cancer- the performance of oral cytology and HRME as an adjunct for triage of visible lesions for biopsy and the performance of HRME as an adjunct to enable better within-lesion targeting of areas for biopsy. If successful, this study would facilitate the development of a non-invasive, 3-step algorithm for oral cancer screening: identification of lesions through visual inspection, triage for biopsy through cytology or HRME, and targeted within-lesion biopsy (if needed) through HRME.

Conditions

Oral Precancer; Oral Cancer; Oral Cancer Screening

Keywords

oral cancer screening

Outcome Measures

Primary Outcomes (1)

• Prevalence of oral dysplasia

  Prevalence of any grade of dysplasia or high-grade dysplasia (moderate dysplasia, severe dysplasia, or cancer)

  At study enrolment

Study Arms (2)

Standard of care arm

ACTIVE COMPARATOR

Patients randomized to the standard of care arm will receive biopsy of visible oral precancer based on clinical assessment.

Other: Standard of care

HRME arm

EXPERIMENTAL

Patients randomized to the HRME arm will receive biopsy of visible oral precancer based on high-resolution microendoscopy assessment.

Device: High-resolution microendoscopy of visible oral precancerous lesions

Interventions

High-resolution microendoscopy of visible oral precancerous lesions DEVICE

high-resolution images of nuclear morphometry within lesions will be obtained in vivo and displayed in real-time on a tablet. A handheld widefield imaging system will capture images with white light. Proflavine solution (0.01% w/v), a fluorescent antiseptic that stains cell nuclei, will be applied locally. The HRME will be placed in contact with each lesion and capture high resolution images from a 790 µm field of view. Optical markers will be calculated for each site imaged, and biopsy areas within lesion will be selected based on optical markers.

Also known as: Standard of care

HRME arm

Standard of care OTHER

Biopsy of ora precancer based on clinical assessment

Standard of care arm

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals aged 30-80 years
• Individuals with visible oral precancerous lesions of at 1 cm in greatest diameter

You may not qualify if:

• Individuals who are undergoing current cancer treatment or had a cancer within the last 12 months
• Individuals who are unwilling or unable to provide informed consent to participate

Sponsors & Collaborators

• Anil Chaturvedi: lead
• National Taiwan University Hospital: collaborator

Study Sites (1)

National Taiwan University Hospital

Taipei, Taipei, 100, Taiwan

RECRUITING

MeSH Terms

Conditions

Mouth Neoplasms

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Anil Chaturvedi, PhD

  Division of Cancer Epidemiology and Genetics, National Cancer Institute

  PRINCIPAL INVESTIGATOR

• Philip Castle, PhD

  Division of Cancer Epidemiology and Genetics, National Cancer Institute

  PRINCIPAL INVESTIGATOR

• Cheng-Ping Wang, MD PhD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

• Tseng-Cheng Chen

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kelly Yu, PhD

CONTACT

240-276-7041; yuke@mail.nih.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Senior Investigator

Model Details: Participants will be randomized individually to one of the two study arms. 1. In the clinician-directed biopsy arm, the clinician will take biopsy(s) from the predetermined location from the initial clinical assessment. 2. In the HRME-directed biopsy arm, the clinician will take biopsies from lesion areas based on the prerecorded HRME reading.

Study Record Dates

• First Submitted: December 1, 2025
• First Posted: December 3, 2025
• Study Start: December 15, 2025
• Primary Completion (Estimated): January 30, 2028
• Study Completion (Estimated): January 30, 2029
• Last Updated: April 14, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Upon publication of study results
• Access Criteria: Deidentified data can be accessed by contacting the study team

Locations

TW (1)