Clinical trial · Observational
Non-invasive Methods for Oral Cancer Screening
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Oral Cancer Screening | Oral Cavity Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Whether the biopsy sites are consistent
- timeFrame
- one month
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 30 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: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). The rationale for including those with history of cancer is that they are still at risk of developing oral cavity cancer and therefore will benefit from a better screening algorithm. Also, in our experience lesions in cancer survivors are phenotypically similar to those without a prior history of head and neck cancer. Only lesions with at least 1 cm in greatest diameter will be considered eligible. Additionally, because there could be issues in HRME imaging due to keratinization at some anatomic sites, we will divide lesions into approximate quadrants and exclude any lesions that do not have good nuclear resolution on at least one representative image per quadrant. \- Exclusion Criteria:We exclude those who: 1) are undergoing current cancer treatment or had a cancer within the last two years to avoid any effects of the cancer treatments; 2) are unwilling or unable to provide informed consent to participate; and/or 3) based on clinical judgement, should not be included in the study e.g., has other medical conditions that would preclude them from participating. \-
References
Publications (0)
Data not yet available