NCT01919567

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
255

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2011

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

August 7, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 9, 2013

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

December 10, 2013

Status Verified

November 1, 2013

Enrollment Period

2.4 years

First QC Date

August 7, 2013

Last Update Submit

December 8, 2013

Conditions

CarcinogenesisOral Cancer

Keywords

SOX-9Oral cancerarecoline

Outcome Measures

Primary Outcomes (1)

  • Carcinogenesis of SOX-9

    3 years

Study Arms (3)

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 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.

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Medical center

You may qualify if:

  • Dysplasia or cancer of the oral cavity.

You may not qualify if:

  • pregnant woman

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital research Ethics Committee

Taipei, 10048, Taiwan

RECRUITING

Related 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. doi: 10.1038/sj.onc.1205985.

    PMID: 12420222BACKGROUND

  • 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. doi: 10.1038/sj.bjc.6604143. Epub 2007 Dec 18.

    PMID: 18087279BACKGROUND

  • Alvarez-Medina R, Le Dreau G, Ros M, Marti 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.

    PMID: 19736325BACKGROUND

  • 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. doi: 10.1093/hmg/ddm061. Epub 2007 Apr 4.

    PMID: 17409199BACKGROUND

  • Lu 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.

    PMID: 19019766BACKGROUND

  • 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. doi: 10.1038/sj.onc.1207603.

    PMID: 15077158BACKGROUND

  • 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.

    PMID: 18339840BACKGROUND

  • 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. doi: 10.1158/0008-5472.CAN-04-1484.

    PMID: 15781631BACKGROUND

  • 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. doi: 10.1159/000074336.

    PMID: 14684982BACKGROUND

  • 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. doi: 10.1186/1476-4598-6-62.

    PMID: 17922924BACKGROUND

  • 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. doi: 10.1093/nar/27.5.1359.

    PMID: 9973626BACKGROUND

  • 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. doi: 10.1016/s0304-3835(00)00533-4.

    PMID: 10974408BACKGROUND

  • 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.

    PMID: 19931241BACKGROUND

  • 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.

    PMID: 19644932BACKGROUND

  • 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. doi: 10.1083/jcb.200311021.

    PMID: 15240568BACKGROUND

  • 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. No abstract available.

    PMID: 19249237BACKGROUND

  • 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.

    PMID: 19665921BACKGROUND

  • 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.

    PMID: 18333897BACKGROUND

  • 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. doi: 10.1002/jez.1089.

    PMID: 11555853BACKGROUND

  • 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.

    PMID: 20651055BACKGROUND

  • 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. doi: 10.1210/er.2002-0025.

    PMID: 12920151BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

tissue, serum, saliva

MeSH Terms

Conditions

CarcinogenesisMouth Neoplasms

Condition Hierarchy (Ancestors)

Neoplastic ProcessesNeoplasmsPathologic ProcessesPathological Conditions, Signs and SymptomsHead and Neck NeoplasmsNeoplasms by SiteMouth DiseasesStomatognathic Diseases

Study Officials

  • Shin-Jung Cheng, DDS, MS, PhD

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shin-Jung Cheng, DDS, MS, PhD

CONTACT

+886 2 29251733sjcheng56@ntu.edu.tw

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 7, 2013

First Posted

August 9, 2013

Study Start

November 1, 2011

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

December 10, 2013

Record last verified: 2013-11

Locations

TW(1)