The Study of p62/SQSTM1 as a Malignant Transformation Marker for Oral Potentially Malignant Disorders and a Prognostic Marker for Oral Squamous Cell Carcinoma

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Brief 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

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

Brief 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. 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 Type

Observational [Patient Registry]


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


Condition

Oral Potentially Malignant Disorder



Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

2000

Start Date

June 2014


Primary Completion Date

August 2014

Eligibility Criteria

        Inclusion Criteria:

        Study group was oral precancerous lesions in patients with malignant transformation;
        control group was generally no precancerous disease and orthodontic surgery volunteer

        Exclusion Criteria:

        Oral mucosa of subjects is too thin
      

Gender

All

Ages

20 Years - 90 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Chen Hsin Ming, PHD, 886-23123456, [email protected]



Administrative Informations


NCT ID

NCT01946230

Organization ID

201306005RINC


Responsible Party

Sponsor

Study Sponsor

National Taiwan University Hospital


Study Sponsor

Chen Hsin Ming, PHD, Principal Investigator, National Taiwan University Hospital


Verification Date

April 2014