NCT07249437

Brief Summary

Oral cancer is a common cancer worldwide, with approximately 250,000 new cases annually and a high mortality rate. Its major risk factors include smoking, alcohol consumption, and betel nut chewing. Current screening methods rely heavily on visual inspection by specialist physicians and invasive biopsy of lesions, but they suffer from limitations such as insufficient sensitivity, sampling errors in biopsies, and low patient compliance. This study proposes an innovative cross-sectional randomized trial aimed at evaluating two non-invasive techniques-oral digital imaging photography (high-resolution microendoscopy, HRME) and liquid-based cytology (LBC) of the oral mucosa-in order to optimize the screening of oral precancerous lesions.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
12mo left

Started May 2025

Geographic Reach
1 country

1 active site

Status
active not recruiting

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 Progress51%
May 2025Apr 2027

Study Start

First participant enrolled

May 1, 2025

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 18, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 25, 2025

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2027

Last Updated

November 25, 2025

Status Verified

November 1, 2025

Enrollment Period

2 years

First QC Date

November 18, 2025

Last Update Submit

November 18, 2025

Conditions

Oral Cancer Screening

Keywords

oral cancerhigh-resolution microendoscopy (HRME)

Outcome Measures

Primary Outcomes (1)

  • Whether the biopsy sites are consistent

    Whether the biopsy site selected based on conventional physician visual inspection is the same area as the biopsy site selected with the assistance of oral digital imaging (high-resolution microendoscopy, HRME) each time.

    one month

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

We proposed to include individuals aged 30-80 years with prevalent oral precancer with or without a prior history of head and neck cancer (oral cavity, oropharynx, hypopharynx, larynx).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

Location

Biospecimen

Retention: SAMPLES WITH DNA

plasma serum buffy-coat+RBC Liquid-Based Cytology，LBC

MeSH Terms

Conditions

Mouth Neoplasms

Condition Hierarchy (Ancestors)

Head and Neck NeoplasmsNeoplasms by SiteNeoplasmsMouth DiseasesStomatognathic Diseases

Study Officials

  • Cheng-Ping Wang, Doctor

    National Taiwan University Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2025

First Posted

November 25, 2025

Study Start

May 1, 2025

Primary Completion (Estimated)

April 30, 2027

Study Completion (Estimated)

April 30, 2027

Last Updated

November 25, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will share

For the needs of this research, the specimens we collect from you will be used in accordance with this research protocol. The specimens will be stored either in the laboratory of Dr. Cheng-Ping Wang at National Taiwan University Hospital or at the U.S. National Institutes of Health (NIH) and will be retained for a maximum of 30 years. Upon expiration of the 30-year storage period, the specimens will be destroyed in accordance with the law. To protect your personal privacy, your name and other personally identifiable information will be replaced with a unique study/research ID number, ensuring that your specimens and related data remain completely confidential.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
2027/4/30\~2057/4/30
Access Criteria
DCEG, NCI Investigator(s): Anil K. Chaturvedi and Philip E. Castle U.S. Co-Investigator(s): Kelly J. Yu (IIB), Hormuzd A. Katki (BB), Li C. Cheung (BB), Maria Demarco (CGB), Mark W. Lingen (University of Chicago), Abberly Lott-Limbach (Ohio State University), Ann Gillenwater (MD Anderson), Rebecca Richards-Kortum (Rice University), Richard Schwarz (Rice University), Nadarajah Vigneswaran (UTHealth School of Dentistry at Houston), and Jennifer Carns Plante (Rice University). Taiwan Co-Investigator(s): Tseng-Cheng Chen (National Taiwan University Hospital), Pei-Jen Lou (National Taiwan University Hospital), Yu-Fong Chang (National Taiwan University Hospital),Min-Shu Hsieh (National Taiwan University Hospital), Chun-Yang Hung(National Taiwan University Hospital) ,and Cheng-Ping Wang (National Taiwan University Hospital)

Locations

TW(1)