Oral Potentially Malignant Disorderp62/SQSTM1NCT01946230
The Study of p62/SQSTM1 as a Malignant Transformation Marker for Oral Potentially Malignant Disorders and a Prognostic Marker for Oral Squamous Cell Carcinoma
An observational study of Oral Potentially Malignant Disorder and Oral Cancer, run by National Taiwan University Hospital.
Trial summary
The mortality rate of oral cancer in Taiwan is still high with no decrease. One of the reasons result in these situations is the patent visits hospital for treatment in late stage of oral cancer. Recently, the government makes effort in oral cancer screening to find oral potentially malignant disorders (OPMD) early. Read more about this study
- Who is it for?
- Ages 20 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Oral Potentially Malignant Disorder, Oral Cancer, Malignant Disorder
- How many people
- 2,000 participants
- Where
- No sites listed yet
- Study dates
- Jun 2014to Aug 2014
- How long will I take part?
- 6 Years
- 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 20 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Doctor of Dental Surgery
Who may be able to join
- Study group was oral precancerous lesions in patients with malignant transformation; control group was generally no precancerous disease and orthodontic surgery volunteer
Who cannot join
- Oral mucosa of subjects is too thin
Trial locations and contacts
No sites are listed yet.
About this study
The mortality rate of oral cancer in Taiwan is still high with no decrease. One of the reasons result in these situations is the patent visits hospital for treatment in late stage of oral cancer. Recently, the government makes effort in oral cancer screening to find oral potentially malignant disorders (OPMD) early. However, there is no conscience in treatment strategies of OPMD up to now. In this study, we will set a OPMD data bank, and use the cases to find out the potential biomarker, which is able to predict the oral cancer malignant transformation. Sixty OPMD with oral cancer transformation will be recruited, and 60 OPMD with no oral cancer malignant transformation will also be enrolled as the disease control group. Besides, 20 normal cases and 60 oral cancer cases resulting from previous OPMD will be collected. All those groups will detect the expression of p62/SQSTM1 to investigate the possibility that p62/SQSTM1 as a biomarker to predict the malignant transformation of OPMM, and a guideline to treat or not to treat OPMD.
- Medical subject headings
- Mouth Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
The study of p62/SQSTM1 as a Malignant Transformation Marker for Oral Potentially Malignant Disorders and a Prognostic Marker for Oral Squamous Cell Carcinoma
Measured: two year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2013 (estimated)
- Study startJun 2014
- Primary completionAug 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral Potentially Malignant DisorderStudies 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
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
- Target duration
- 6 Years
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chen Hsin Ming, PHD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01946230
- Sponsor's protocol ID
- 201306005RINC
- Acronym
- p62/SQSTM1
- Status last verified
- Apr 2014
- First submitted
- 16 Sep 2013
- Last updated
- 28 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Study of p62/SQSTM1 as a Malignant Transformation Marker for Oral Potentially Malignant Disorders and a Prognostic Marker for Oral Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT01946230
- Acronym / sponsor ID
- p62/SQSTM1 / 201306005RINC
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Aug 2014 (estimated)
- First posted
- 19 Sep 2013 (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.
The mortality rate of oral cancer in Taiwan is still high with no decrease. One of the reasons result in these situations is the patent visits hospital for treatment in late stage of oral cancer. Recently, the government makes effort in oral cancer screening to find oral potentially malignant disorders (OPMD) early. However, there is no conscience in treatment strategies of OPMD up to now. In this study, we will set a OPMD data bank, and use the cases to find out the potential biomarker, which is able to predict the oral cancer malignant transformation. Sixty OPMD with oral cancer transformation will be recruited, and 60 OPMD with no oral cancer malignant transformation will also be enrolled as the disease control group. Besides, 20 normal cases and 60 oral cancer cases resulting from previous OPMD will be collected. All those groups will detect the expression of p62/SQSTM1 to investigate the possibility that p62/SQSTM1 as a biomarker to predict the malignant transformation of OPMM, and a guideline to treat or not to treat OPMD.
Study design
- Time perspective
- Prospective
- Target follow-up
- 6 Years
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Doctor of Dental Surgery
Key inclusion criteria (1 listed)
- Study group was oral precancerous lesions in patients with malignant transformation; control group was generally no precancerous disease and orthodontic surgery volunteer
Key exclusion criteria (1 listed)
- Oral mucosa of subjects is too thin
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
The study of p62/SQSTM1 as a Malignant Transformation Marker for Oral Potentially Malignant Disorders and a Prognostic Marker for Oral Squamous Cell Carcinoma
Time frame: two year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2014.
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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.
Chen Hsin Ming, PHD principal investigator
National Taiwan University Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Oral Potentially Malignant Disorder and Oral Cancer, run by National Taiwan University Hospital.
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 1 inclusion and 1 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 28 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
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 Chen Hsin Ming, PHD (886-23123456 ext. 66723, hsinmingchen@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The study of p62/SQSTM1 as a Malignant Transformation Marker for Oral Potentially Malignant Disorders and a Prognostic Marker for Oral Squamous Cell Carcinoma (time frame: two year). 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 28 Apr 2014.