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Trial record 13 of 175 for:    "Lip and oral cavity cancer"

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

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ClinicalTrials.gov Identifier: NCT01919580
Recruitment Status : Unknown
Verified April 2014 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : August 9, 2013
Last Update Posted : April 15, 2014
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

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

Condition or disease
Carcinogenesis Oral Cancer

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.


Study Type : Observational
Estimated Enrollment : 255 participants
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.
Study Start Date : December 2012
Actual Primary Completion Date : April 2014
Estimated Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oral Cancer

Group/Cohort
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.




Primary Outcome Measures :
  1. Carcinogenesis of Gα12 [ Time Frame: 3 years ]

Biospecimen Retention:   Samples With DNA
tissue, serum, saliva


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications of Results:
Other Publications:

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01919580     History of Changes
Other Study ID Numbers: 201112057RIB
First Posted: August 9, 2013    Key Record Dates
Last Update Posted: April 15, 2014
Last Verified: April 2014

Keywords provided by National Taiwan University Hospital:
Gα12
Oral cancer

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