NCT01946230

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.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,000

participants targeted

Target at P75+ for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 16, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 19, 2013

Completed
9 months until next milestone

Study Start

First participant enrolled

June 1, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Last Updated

April 28, 2014

Status Verified

April 1, 2014

Enrollment Period

2 months

First QC Date

September 16, 2013

Last Update Submit

April 25, 2014

Conditions

Oral Potentially Malignant DisorderOral CancerMalignant Disorderp62/SQSTM1

Outcome Measures

Primary Outcomes (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

Age20 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Doctor of Dental Surgery

You may qualify if:

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

You may not qualify if:

  • Oral mucosa of subjects is too thin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Mouth Neoplasms

Condition Hierarchy (Ancestors)

Head and Neck NeoplasmsNeoplasms by SiteNeoplasmsMouth DiseasesStomatognathic Diseases

Study Officials

  • Chen Hsin Ming, PHD

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chen Hsin Ming, PHD

CONTACT

886-23123456hsinmingchen@hotmail.com

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Target Duration
6 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 16, 2013

First Posted

September 19, 2013

Study Start

June 1, 2014

Primary Completion

August 1, 2014

Last Updated

April 28, 2014

Record last verified: 2014-04