Oral Cancer ScreeningHRMENCT07249437
Non-invasive Methods for Oral Cancer Screening
An observational study of Oral Cancer Screening, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Oral Cancer Screening
- How many people
- 400 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 May 2025to 30 Apr 2027
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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).
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.
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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.
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Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Oral cancer is a common malignancy worldwide, with approximately 250,000 new cases diagnosed annually and a high mortality rate. Its primary risk factors are smoking, alcohol consumption, and betel nut chewing. Current screening methods heavily rely on visual inspection by specialist physicians and invasive biopsy of lesions, but they are limited by insufficient sensitivity, biopsy sampling errors, and low patient compliance.
To address these issues, this study proposes an innovative cross-sectional randomized trial to evaluate two non-invasive techniques-high-resolution microendoscopy (HRME) and liquid-based cytology (LBC) of the oral mucosa-with the aim of optimizing screening for oral precancerous lesions.
The study will recruit 400 participants with visually identified oral potentially malignant disorders (e.g., leukoplakia or erythroplakia) and randomly assign them to two groups:
a clinical biopsy group (biopsy site selected based on conventional visual inspection), and an HRME-guided biopsy group (biopsy site directed by high-resolution microendoscopy).
Both groups will also undergo liquid-based cytology (LBC) through collection and analysis of oral mucosal cells.
The study objectives include:
Comparing the detection rates of precancerous lesions (mild, moderate, severe dysplasia, or carcinoma in situ, or invasive cancer) between the two groups; Analyzing the intra-lesional consistency of biopsy sites in both groups; Validating the diagnostic performance of LBC alone or in combination with HRME.
- Conditions
- Oral Cancer Screening
- Keywords
- oral cancer, high-resolution microendoscopy (HRME)
- Medical subject headings
- Mouth Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2025
- Study start1 May 2025
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral Cancer ScreeningStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 400 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Cheng-Ping Wang, Doctor, Study chair, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07249437
- Sponsor's protocol ID
- 202503081RINA
- Acronym
- HRME
- Status last verified
- Nov 2025
- First submitted
- 18 Nov 2025
- Last updated
- 25 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Methods for Oral Cancer Screening
- ClinicalTrials.gov ID
- NCT07249437
- Acronym / sponsor ID
- HRME / 202503081RINA
- Conditions
- Oral Cancer Screening
- Keywords
- oral cancer, high-resolution microendoscopy (HRME)
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 1 May 2025 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 25 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Oral cancer is a common malignancy worldwide, with approximately 250,000 new cases diagnosed annually and a high mortality rate. Its primary risk factors are smoking, alcohol consumption, and betel nut chewing. Current screening methods heavily rely on visual inspection by specialist physicians and invasive biopsy of lesions, but they are limited by insufficient sensitivity, biopsy sampling errors, and low patient compliance.
To address these issues, this study proposes an innovative cross-sectional randomized trial to evaluate two non-invasive techniques-high-resolution microendoscopy (HRME) and liquid-based cytology (LBC) of the oral mucosa-with the aim of optimizing screening for oral precancerous lesions.
The study will recruit 400 participants with visually identified oral potentially malignant disorders (e.g., leukoplakia or erythroplakia) and randomly assign them to two groups:
a clinical biopsy group (biopsy site selected based on conventional visual inspection), and an HRME-guided biopsy group (biopsy site directed by high-resolution microendoscopy).
Both groups will also undergo liquid-based cytology (LBC) through collection and analysis of oral mucosal cells.
The study objectives include:
Comparing the detection rates of precancerous lesions (mild, moderate, severe dysplasia, or carcinoma in situ, or invasive cancer) between the two groups; Analyzing the intra-lesional consistency of biopsy sites in both groups; Validating the diagnostic performance of LBC alone or in combination with HRME.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Whether the biopsy sites are consistent
Time frame: one month
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2025.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cheng-Ping Wang, Doctor study chair
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oral Cancer Screening, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 25 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Whether the biopsy sites are consistent (time frame: one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2025.