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

April 25, 2014 updated by: National Taiwan University Hospital
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 Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 86 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Doctor of Dental Surgery

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
two year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Anticipated)

August 1, 2014

Study Registration Dates

First Submitted

September 16, 2013

First Submitted That Met QC Criteria

September 16, 2013

First Posted (Estimate)

September 19, 2013

Study Record Updates

Last Update Posted (Estimate)

April 28, 2014

Last Update Submitted That Met QC Criteria

April 25, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201306005RINC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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