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

NCT ID: NCT01919580

Last Updated: 2014-04-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

255 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-12-31

Study Completion Date

2014-07-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Carcinogenesis Oral Cancer

Study Design

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Observational Model Type

CASE_CONTROL

Study Groups

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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.

No interventions assigned to this group

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Dysplasia or cancer of the oral cavity.

Exclusion Criteria

* pregnant woman
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shin-Jung Cheng, DDS, MS, PhD

Role: PRINCIPAL_INVESTIGATOR

Locations

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National Taiwan University Hospital research Ethics Committee

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Shin-Jung Cheng, DDS, MS, PhD

Role: CONTACT

+886 2 29251733 ext. 67509

Facility Contacts

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Shin-Jung Cheng, DDS, MS, PhD

Role: primary

+886 2 29251733 ext. 67509

References

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Yu YP, Landsittel D, Jing L, Nelson J, Ren B, Liu L, McDonald C, Thomas R, Dhir R, Finkelstein S, Michalopoulos G, Becich M, Luo JH. Gene expression alterations in prostate cancer predicting tumor aggression and preceding development of malignancy. J Clin Oncol. 2004 Jul 15;22(14):2790-9. doi: 10.1200/JCO.2004.05.158.

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Buhl AM, Johnson NL, Dhanasekaran N, Johnson GL. G alpha 12 and G alpha 13 stimulate Rho-dependent stress fiber formation and focal adhesion assembly. J Biol Chem. 1995 Oct 20;270(42):24631-4. doi: 10.1074/jbc.270.42.24631.

Reference Type RESULT
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Chan AM, Fleming TP, McGovern ES, Chedid M, Miki T, Aaronson SA. Expression cDNA cloning of a transforming gene encoding the wild-type G alpha 12 gene product. Mol Cell Biol. 1993 Feb;13(2):762-8. doi: 10.1128/mcb.13.2.762-768.1993.

Reference Type RESULT
PMID: 8423800 (View on PubMed)

Other Identifiers

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201112057RIB

Identifier Type: -

Identifier Source: org_study_id

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