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Study on the Carcinogenesis of SOX-9 in Oral Cancer, and Chemopreventive Possibility for the Treatment of Oral Cancer.

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ClinicalTrials.gov Identifier: NCT01919567
Recruitment Status : Unknown
Verified November 2013 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : August 9, 2013
Last Update Posted : December 10, 2013
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

August 7, 2013
August 9, 2013
December 10, 2013
November 2011
April 2014   (Final data collection date for primary outcome measure)
Carcinogenesis of SOX-9 [ Time Frame: 3 years ]
Same as current
Complete list of historical versions of study NCT01919567 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Study on the Carcinogenesis of SOX-9 in Oral Cancer, and Chemopreventive Possibility for the Treatment of Oral Cancer.
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 on the Carcinogenesis of SOX-9 in Oral Cancer, and Chemopreventive Possibility for the Treatment of Oral Cancer Using SOX-9 Inhibitor.

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.

Observational
Observational Model: Case Control
Not Provided
Retention:   Samples With DNA
Description:
tissue, serum, saliva
Probability Sample
Medical center
  • Carcinogenesis
  • Oral Cancer
Not Provided
  • Normal team

    Subjects who have problem at third molar of impacted tooth need to receive a surgery with general anesthesia.

    Subjects must:

    Should have a blood exam (20ml) before the surgery.

    Site staff must:

    Collect subjects' saliva once a day (in the morning before breakfast) for 3 consecutive days.

    Collect a 0.5x0.5Cm2 tissue sample around third molar during the surgery.

  • Oral dysplasia

    Subjects who are diagnosed with dysplasia of oral cavity.

    Subjects must:

    Should have a blood exam (20ml/each time) before the surgery and 3 months after the surgery.

    In the case the disease recurs after the surgery, subjects need to receive the surgery again and take another blood exam before the surgery and 3 months after the surgery.

    Before the surgery site staff must:

    Collect saliva once a day (in the morning before breakfast) for 3 consecutive days.

    Collect a 0.5x0.5Cm2 tissue sample of the tumor during the surgery.

  • Oral cancer

    Subjects who suffer from oral cancer.

    Subjects must:

    Should have a blood exam (20ml/each time) before the surgery and 3 months after the surgery.

    In the case the disease recurs after the surgery, subjects need to receive the surgery again and take another blood exam before the surgery and 3 months after the surgery.

    Before the surgery site staff must:

    Collect subjects' saliva once a day (in the morning before breakfast) for 3 consecutive days.

    Collect a 0.5x0.5Cm2 tissue sample of the tumor during the surgery.


*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
255
Same as current
April 2014
April 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Dysplasia or cancer of the oral cavity.

Exclusion Criteria:

  • pregnant woman
Sexes Eligible for Study: All
20 Years to 80 Years   (Adult, Older Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Taiwan
 
 
NCT01919567
201012095RC
Yes
Not Provided
Not Provided
National Taiwan University Hospital
National Taiwan University Hospital
Not Provided
Principal Investigator: Shin-Jung Cheng, DDS, MS, PhD
National Taiwan University Hospital
November 2013