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

Oral Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01919580
• Other study ID #: 201112057RIB
• Status: Recruiting
• Phase: N/A
• First received: August 7, 2013
• Last updated: April 14, 2014
• Start date: December 2012
• Est. completion date: July 2014

Study information

• Verified date: April 2014
• Source: National Taiwan University Hospital
• Contact: Shin-Jung Cheng, DDS, MS, PhD
• Phone: +886 2 29251733
• Email: sjcheng56[@]ntu.edu.tw
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 255
• Est. completion date: July 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• Dysplasia or cancer of the oral cavity.

Exclusion Criteria:

• pregnant woman

Study Design

Observational Model: Case Control

Related Conditions & MeSH terms

• Carcinogenesis
• Lip Neoplasms
• Mouth Neoplasms
• Oral Cancer

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital research Ethics Committee	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (16)

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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. — View Citation

Dolezalova H, Shankar G, Huang MC, Bikle DD, Goetzl EJ. Biochemical regulation of breast cancer cell expression of S1P2 (Edg-5) and S1P3 (Edg-3) G protein-coupled receptors for sphingosine 1-phosphate. J Cell Biochem. 2003 Mar 1;88(4):732-43. — View Citation

Dorsam RT, Gutkind JS. G-protein-coupled receptors and cancer. Nat Rev Cancer. 2007 Feb;7(2):79-94. Review. — View Citation

Etienne-Manneville S, Hall A. Rho GTPases in cell biology. Nature. 2002 Dec 12;420(6916):629-35. Review. — View Citation

Friedl P, Wolf K. Tumour-cell invasion and migration: diversity and escape mechanisms. Nat Rev Cancer. 2003 May;3(5):362-74. Review. — View Citation

Gilman AG. G proteins: transducers of receptor-generated signals. Annu Rev Biochem. 1987;56:615-49. Review. — View Citation

Gohla A, Offermanns S, Wilkie TM, Schultz G. Differential involvement of Galpha12 and Galpha13 in receptor-mediated stress fiber formation. J Biol Chem. 1999 Jun 18;274(25):17901-7. — View Citation

Gu JL, Müller S, Mancino V, Offermanns S, Simon MI. Interaction of G alpha(12) with G alpha(13) and G alpha(q) signaling pathways. Proc Natl Acad Sci U S A. 2002 Jul 9;99(14):9352-7. Epub 2002 Jun 20. — View Citation

Meigs TE, Fedor-Chaiken M, Kaplan DD, Brackenbury R, Casey PJ. Galpha12 and Galpha13 negatively regulate the adhesive functions of cadherin. J Biol Chem. 2002 Jul 5;277(27):24594-600. Epub 2002 Apr 25. — View Citation

Moers A, Nürnberg A, Goebbels S, Wettschureck N, Offermanns S. Galpha12/Galpha13 deficiency causes localized overmigration of neurons in the developing cerebral and cerebellar cortices. Mol Cell Biol. 2008 Mar;28(5):1480-8. Epub 2007 Dec 17. — View Citation

Parks S, Wieschaus E. The Drosophila gastrulation gene concertina encodes a G alpha-like protein. Cell. 1991 Jan 25;64(2):447-58. — View Citation

Radeff-Huang J, Seasholtz TM, Matteo RG, Brown JH. G protein mediated signaling pathways in lysophospholipid induced cell proliferation and survival. J Cell Biochem. 2004 Aug 1;92(5):949-66. Review. — View Citation

Radhika V, Hee Ha J, Jayaraman M, Tsim ST, Dhanasekaran N. Mitogenic signaling by lysophosphatidic acid (LPA) involves Galpha12. Oncogene. 2005 Jun 30;24(28):4597-603. — View Citation

Xu J, Wang F, Van Keymeulen A, Herzmark P, Straight A, Kelly K, Takuwa Y, Sugimoto N, Mitchison T, Bourne HR. Divergent signals and cytoskeletal assemblies regulate self-organizing polarity in neutrophils. Cell. 2003 Jul 25;114(2):201-14. — View Citation

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. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Carcinogenesis of Ga12		3 years	No