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

Sponsor
National Taiwan University Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT01946230
Collaborator
(none)
2,000
Enrollment

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    2000 participants
    Time Perspective:
    Prospective
    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
    Study Start Date :
    Jun 1, 2014
    Anticipated Primary Completion Date :
    Aug 1, 2014

    Outcome Measures

    Primary Outcome Measures

    1. The study of p62/SQSTM1 as a Malignant Transformation Marker for Oral Potentially Malignant Disorders and a Prognostic Marker for Oral Squamous Cell Carcinoma [two year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • National Taiwan University Hospital

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    National Taiwan University Hospital
    ClinicalTrials.gov Identifier:
    NCT01946230
    Other Study ID Numbers:
    • 201306005RINC
    First Posted:
    Sep 19, 2013
    Last Update Posted:
    Apr 28, 2014
    Last Verified:
    Apr 1, 2014
    Additional relevant MeSH terms:
    Carcinoma, Squamous Cell
    Mouth Neoplasms
    Squamous Cell Carcinoma of Head and Neck
    Disease

    Study Results

    No Results Posted as of Apr 28, 2014