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

Oral Cancer Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01919567
• Other study ID #: 201012095RC
• Status: Recruiting
• Phase: N/A
• First received: August 7, 2013
• Last updated: December 8, 2013
• Start date: November 2011
• Est. completion date: April 2014

Study information

• Verified date: November 2013
• 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 SOX-9 in Oral Cancer, and Chemopreventive Possibility for the Treatment of Oral Cancer Using SOX-9 Inhibitor.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 255
• Est. completion date: April 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 (21)

Afonja O, Raaka BM, Huang A, Das S, Zhao X, Helmer E, Juste D, Samuels HH. RAR agonists stimulate SOX9 gene expression in breast cancer cell lines: evidence for a role in retinoid-mediated growth inhibition. Oncogene. 2002 Nov 7;21(51):7850-60. — View Citation

Aleman A, Adrien L, Lopez-Serra L, Cordon-Cardo C, Esteller M, Belbin TJ, Sanchez-Carbayo M. Identification of DNA hypermethylation of SOX9 in association with bladder cancer progression using CpG microarrays. Br J Cancer. 2008 Jan 29;98(2):466-73. Epub 2007 Dec 18. — View Citation

Alvarez-Medina R, Le Dreau G, Ros M, Martí E. Hedgehog activation is required upstream of Wnt signalling to control neural progenitor proliferation. Development. 2009 Oct;136(19):3301-9. doi: 10.1242/dev.041772. — View Citation

Bien-Willner GA, Stankiewicz P, Lupski JR. SOX9cre1, a cis-acting regulatory element located 1.1 Mb upstream of SOX9, mediates its enhancement through the SHH pathway. Hum Mol Genet. 2007 May 15;16(10):1143-56. Epub 2007 Apr 4. — View Citation

Blache P, van de Wetering M, Duluc I, Domon C, Berta P, Freund JN, Clevers H, Jay P. SOX9 is an intestine crypt transcription factor, is regulated by the Wnt pathway, and represses the CDX2 and MUC2 genes. J Cell Biol. 2004 Jul 5;166(1):37-47. — View Citation

de Camargo Cancela M, Voti L, Guerra-Yi M, Chapuis F, Mazuir M, Curado MP. Oral cavity cancer in developed and in developing countries: population-based incidence. Head Neck. 2010 Mar;32(3):357-67. doi: 10.1002/hed.21193. — View Citation

Drivdahl R, Haugk KH, Sprenger CC, Nelson PS, Tennant MK, Plymate SR. Suppression of growth and tumorigenicity in the prostate tumor cell line M12 by overexpression of the transcription factor SOX9. Oncogene. 2004 Jun 3;23(26):4584-93. — View Citation

Fracalossi AC, Silva Mde S, Oshima CT, Ribeiro DA. Wnt/beta-catenin signalling pathway following rat tongue carcinogenesis induced by 4-nitroquinoline 1-oxide. Exp Mol Pathol. 2010 Feb;88(1):176-83. doi: 10.1016/j.yexmp.2009.11.004. Epub 2009 Nov 17. — View Citation

Harley VR, Clarkson MJ, Argentaro A. The molecular action and regulation of the testis-determining factors, SRY (sex-determining region on the Y chromosome) and SOX9 [SRY-related high-mobility group (HMG) box 9]. Endocr Rev. 2003 Aug;24(4):466-87. Review. — View Citation

Ishida K, Ito S, Wada N, Deguchi H, Hata T, Hosoda M, Nohno T. Nuclear localization of beta-catenin involved in precancerous change in oral leukoplakia. Mol Cancer. 2007 Oct 9;6:62. — View Citation

Jay P, Berta P, Blache P. Expression of the carcinoembryonic antigen gene is inhibited by SOX9 in human colon carcinoma cells. Cancer Res. 2005 Mar 15;65(6):2193-8. — View Citation

Jiang SS, Fang WT, Hou YH, Huang SF, Yen BL, Chang JL, Li SM, Liu HP, Liu YL, Huang CT, Li YW, Jang TH, Chan SH, Yang SJ, Hsiung CA, Wu CW, Wang LH, Chang IS. Upregulation of SOX9 in lung adenocarcinoma and its involvement in the regulation of cell growth and tumorigenicity. Clin Cancer Res. 2010 Sep 1;16(17):4363-73. doi: 10.1158/1078-0432.CCR-10-0138. Epub 2010 Jul 22. — View Citation

Knower KC, Kelly S, Harley VR. Turning on the male--SRY, SOX9 and sex determination in mammals. Cytogenet Genome Res. 2003;101(3-4):185-98. Review. — View Citation

Koopman P, Bullejos M, Bowles J. Regulation of male sexual development by Sry and Sox9. J Exp Zool. 2001 Sep 15;290(5):463-74. Review. — View Citation

Lü B, Fang Y, Xu J, Wang L, Xu F, Xu E, Huang Q, Lai M. Analysis of SOX9 expression in colorectal cancer. Am J Clin Pathol. 2008 Dec;130(6):897-904. doi: 10.1309/AJCPW1W8GJBQGCNI. — View Citation

Mertin S, McDowall SG, Harley VR. The DNA-binding specificity of SOX9 and other SOX proteins. Nucleic Acids Res. 1999 Mar 1;27(5):1359-64. — View Citation

Murata M, Iwao K, Miyoshi Y, Nagasawa Y, Yabu M, Himeno S, Imanishi K, Ohsawa M, Wada H, Tominaga S, Shimano T, Kobayashi T, Nakamura Y. Activation of the beta-catenin gene by interstitial deletions involving exon 3 as an early event in colorectal tumorigenesis. Cancer Lett. 2000 Oct 16;159(1):73-8. — View Citation

Scully C, Bagan J. Oral squamous cell carcinoma overview. Oral Oncol. 2009 Apr-May;45(4-5):301-8. doi: 10.1016/j.oraloncology.2009.01.004. Epub 2009 Feb 26. Review. — View Citation

Supic G, Kozomara R, Brankovic-Magic M, Jovic N, Magic Z. Gene hypermethylation in tumor tissue of advanced oral squamous cell carcinoma patients. Oral Oncol. 2009 Dec;45(12):1051-7. doi: 10.1016/j.oraloncology.2009.07.007. Epub 2009 Aug 8. — View Citation

Vidal VP, Ortonne N, Schedl A. SOX9 expression is a general marker of basal cell carcinoma and adnexal-related neoplasms. J Cutan Pathol. 2008 Apr;35(4):373-9. doi: 10.1111/j.1600-0560.2007.00815.x. — View Citation

Wang H, Leav I, Ibaragi S, Wegner M, Hu GF, Lu ML, Balk SP, Yuan X. SOX9 is expressed in human fetal prostate epithelium and enhances prostate cancer invasion. Cancer Res. 2008 Mar 15;68(6):1625-30. doi: 10.1158/0008-5472.CAN-07-5915. — View Citation

* Note: There are 21 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Carcinogenesis of SOX-9		3 years	No