Clinical trial NCT01919567: Study on the Carcinogenesis of SOX-9 in Oral Cancer, and Chemopreventive Possibility for the Treatment of Oral Cancer.
Official title: Observational Study on the Carcinogenesis of SOX-9 in Oral Cancer, and Chemopreventive Possibility for the Treatment of Oral Cancer Using SOX-9 Inhibitor.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Carcinogenesis
Oral Cancer
Keywords: SOX-9
Oral cancer
arecoline
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2013-08-09
Enrollment: 255
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Sampling method: PROBABILITY_SAMPLE
Study population: Medical center

Brief summary: Study on the Carcinogenesis of SOX-9 in Oral Cancer, and Chemopreventive Possibility for the Treatment of Oral Cancer Using SOX-9 Inhibitor.

Detailed description: To find out if there is prognostic value which to the performance of SOX-9 of oral cancer in Taiwan and provide some reference for future treatment.

We anticipate to enroll 40 persons with normal oral mucosa, 65 persons with oral dysplasia and 150 persons with oral cancer and collect the tissue which was stained for pathological sections over a 3 year period.

We also collect the blood and saliva samples from patients and the results along with patient-specific information such as tumor phases, tumor size, lymph node metastasis, cancer metastasis, prognosis and betel nut chewing, smoking and drinking habits and other parameters are statistically analyzed.

Eligibility criteria: Inclusion Criteria:

* Dysplasia or cancer of the oral cavity.

Exclusion Criteria:

* pregnant woman

Primary outcomes:
measure: Carcinogenesis of SOX-9
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital research Ethics Committee
Study officials:
name: Shin-Jung Cheng, DDS, MS, PhD
role: PRINCIPAL_INVESTIGATOR
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