Oral LeukoplakiaNCT00767442
Least Invasive Nonlinear Light Microscopy
An observational study of Oral Leukoplakia and Oral Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Evaluate the ability to image oral mucosa in healthy volunteer by nonlinear microscopy Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Oral Leukoplakia, Oral Cancer
- Type of treatment
- Pill or oral medicine
- How many people
- 10 participants
- Where
- 1 siteTaiwan
- Study dates
- Dec 2008to Dec 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Clinics
Who may be able to join
- Health volunteer
- Patient with suspected oral mucosa lesion
Who cannot join
- Active infectious disease
- Inability to cooperate
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, TW, 100
WJ Lee, MD, 886-2-23123456 ext. 65586, wenjeng@gmail.com
About this study
Evaluate the ability to image oral mucosa in healthy volunteer by nonlinear microscopy
- Conditions
- Oral Leukoplakia, Oral Cancer
- Medical subject headings
- Leukoplakia, Oral, Mouth Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Health volunteer | |
| 2 | Patient with suspected oral mucosa lesion |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2008 (estimated)
- Study startDec 2008
- Primary completionDec 2009 (estimated)
- Study completionDec 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral LeukoplakiaStudies 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-control
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Health Research Institutes, Taiwan
- Investigators
- Wen-Jeng Lee, M.D., Principal investigator, NTUH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00767442
- Sponsor's protocol ID
- 200806021D
- Status last verified
- Dec 2009
- First submitted
- 6 Oct 2008
- Last updated
- 15 Dec 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Least Invasive Nonlinear Light Microscopy
- ClinicalTrials.gov ID
- NCT00767442
- Acronym / sponsor ID
- 200806021D
- Conditions
- Oral Leukoplakia, Oral Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- National Health Research Institutes, Taiwan
- Study start
- Dec 2008
- Primary completion
- Dec 2009 (estimated)
- Study completion
- Dec 2009 (estimated)
- First posted
- 7 Oct 2008 (estimated)
- 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.
Evaluate the ability to image oral mucosa in healthy volunteer by nonlinear microscopy
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Health volunteer |
| 2 | – | –Patient with suspected oral mucosa lesion |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Clinics
Key inclusion criteria (2 listed)
- Health volunteer
- Patient with suspected oral mucosa lesion
Key exclusion criteria (2 listed)
- Active infectious disease
- Inability to cooperate
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
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2009.
Related trials for Oral Leukoplakia
Active, not recruitingPhase 2
Metformin for the Prevention of Oral Cancer in Patients With Oral Leukoplakia or Erythroplakia
Erythroplakia, Oral Leukoplakia
Active, not recruiting
Widefield Fluorescence and Reflectance Imaging Systems and Oral Tissue Samples in Monitoring Participants at Risk for Developing Oral Cancer
Erythroplakia, Fanconi Anemia
RecruitingPhase 2
Pembrolizumab in Treating Participants With Leukoplakia
Erythroleukoplakia, Leukoplakia
RecruitingPhase 2
Pioglitazone-Metformin Combination Treatment for High Risk Oral Preneoplasia
Oral Leukoplakia
Enrolling by invitation
The Importance of Mucosal Screening in the Prevention of Oral Cancer.
OPMD, Oral Cancer , Oral Squamous Cell Carcinoma, Oral Cavity Cancer
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.
Wen-Jeng Lee, M.D. principal investigator
NTUH
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 Leukoplakia and Oral Cancer, 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?
The sponsor lists 2 inclusion and 2 exclusion criteria. 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: status not confirmed, as of the sponsor's last update on 15 Dec 2009. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wen-Jeng Lee, M.D (886-2-23123456 ext. 65586, wenjeng@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 15 Dec 2009.