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

Sponsor
National Taiwan University Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT01919567
Collaborator
(none)
255
1
29
8.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    255 participants
    Observational Model:
    Case-Control
    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 Start Date :
    Nov 1, 2011
    Anticipated Primary Completion Date :
    Apr 1, 2014
    Anticipated Study Completion Date :
    Apr 1, 2014

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

    1. Carcinogenesis of SOX-9 [3 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Dysplasia or cancer of the oral cavity.
    Exclusion Criteria:
    • pregnant woman

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 National Taiwan University Hospital research Ethics Committee Taipei Taiwan 10048

    Sponsors and Collaborators

    • National Taiwan University Hospital

    Investigators

    • Principal Investigator: Shin-Jung Cheng, DDS, MS, PhD,

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    National Taiwan University Hospital
    ClinicalTrials.gov Identifier:
    NCT01919567
    Other Study ID Numbers:
    • 201012095RC
    First Posted:
    Aug 9, 2013
    Last Update Posted:
    Dec 10, 2013
    Last Verified:
    Nov 1, 2013
    Keywords provided by National Taiwan University Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Dec 10, 2013