Study on the Carcinogenesis of Gα12 in Oral Cancer, and the Treatment of Oral Cancer Using Ga12 Inhibitor.

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by National Taiwan University Hospital
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01919580
First received: August 7, 2013
Last updated: April 14, 2014
Last verified: April 2014
  Purpose

Study on the carcinogenesis of Gα12 in oral cancer, and chemopreventive possibility for the treatment of oral cancer using Ga12 inhibitor.


Condition
Carcinogenesis
Oral Cancer

Study Type: Observational
Study Design: Observational Model: Case Control
Official Title: Observational Study on the Carcinogenesis of Gα12 in Oral Cancer, and Chemopreventive Possibility for the Treatment of Oral Cancer Using Ga12 Inhibitor.

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • Carcinogenesis of Gα12 [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

tissue, serum, saliva


Estimated Enrollment: 255
Study Start Date: December 2012
Estimated Study Completion Date: July 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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 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.

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.


Detailed Description:

To find out if there is prognostic value which to the performance of Gα12 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

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Medical center

Criteria

Inclusion Criteria:

  • Dysplasia or cancer of the oral cavity.

Exclusion Criteria:

  • pregnant woman
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01919580

Contacts
Contact: Shin-Jung Cheng, DDS, MS, PhD +886 2 29251733 ext 67509 sjcheng56@ntu.edu.tw

Locations
Taiwan
National Taiwan University Hospital research Ethics Committee Recruiting
Taipei, Taiwan, 10048
Contact: Shin-Jung Cheng, DDS, MS, PhD    +886 2 29251733 ext 67509    sjcheng56@ntu.edu.tw   
Principal Investigator: Shin-Jung Cheng, DDS, MS, PhD         
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Shin-Jung Cheng, DDS, MS, PhD
  More Information

Publications:

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01919580     History of Changes
Other Study ID Numbers: 201112057RIB
Study First Received: August 7, 2013
Last Updated: April 14, 2014
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
Gα12
Oral cancer

Additional relevant MeSH terms:
Carcinogenesis
Lip Neoplasms
Mouth Neoplasms
Head and Neck Neoplasms
Lip Diseases
Mouth Diseases
Neoplasms
Neoplasms by Site
Neoplastic Processes
Pathologic Processes
Stomatognathic Diseases

ClinicalTrials.gov processed this record on October 20, 2014