Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2026-01-03 @ 1:05 PM
Study NCT ID:
NCT01919567
Status:
UNKNOWN
Last Update Posted:
2013-12-10
First Post:
2013-08-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study on the Carcinogenesis of SOX-9 in Oral Cancer, and Chemopreventive Possibility for the Treatment of Oral Cancer.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D063646', 'term': 'Carcinogenesis'}, {'id': 'D009062', 'term': 'Mouth Neoplasms'}], 'ancestors': [{'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'tissue, serum, saliva'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 255}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'completionDateStruct': {'date': '2014-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-12-08', 'studyFirstSubmitDate': '2013-08-07', 'studyFirstSubmitQcDate': '2013-08-08', 'lastUpdatePostDateStruct': {'date': '2013-12-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-08-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Carcinogenesis of SOX-9', 'timeFrame': '3 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['SOX-9', 'Oral cancer', 'arecoline'], 'conditions': ['Carcinogenesis', 'Oral Cancer']}, 'referencesModule': {'references': [{'pmid': '12420222', 'type': 'BACKGROUND', 'citation': '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': '18087279', 'type': 'BACKGROUND', '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. doi: 10.1038/sj.bjc.6604143. Epub 2007 Dec 18.'}, {'pmid': '19736325', 'type': 'BACKGROUND', 'citation': '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': '17409199', 'type': 'BACKGROUND', '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. doi: 10.1093/hmg/ddm061. Epub 2007 Apr 4.'}, {'pmid': '19019766', 'type': 'BACKGROUND', 'citation': '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': '15077158', 'type': 'BACKGROUND', '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. doi: 10.1038/sj.onc.1207603.'}, {'pmid': '18339840', 'type': 'BACKGROUND', '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.'}, {'pmid': '15781631', 'type': 'BACKGROUND', '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. doi: 10.1158/0008-5472.CAN-04-1484.'}, {'pmid': '14684982', 'type': 'BACKGROUND', '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. doi: 10.1159/000074336.'}, {'pmid': '17922924', 'type': 'BACKGROUND', '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. doi: 10.1186/1476-4598-6-62.'}, {'pmid': '9973626', 'type': 'BACKGROUND', '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. doi: 10.1093/nar/27.5.1359.'}, {'pmid': '10974408', 'type': 'BACKGROUND', '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. doi: 10.1016/s0304-3835(00)00533-4.'}, {'pmid': '19931241', 'type': 'BACKGROUND', '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.'}, {'pmid': '19644932', 'type': 'BACKGROUND', '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.'}, {'pmid': '15240568', 'type': 'BACKGROUND', '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. doi: 10.1083/jcb.200311021.'}, {'pmid': '19249237', 'type': 'BACKGROUND', '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. No abstract available.'}, {'pmid': '19665921', 'type': 'BACKGROUND', '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.'}, {'pmid': '18333897', 'type': 'BACKGROUND', '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.'}, {'pmid': '11555853', 'type': 'BACKGROUND', '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. doi: 10.1002/jez.1089.'}, {'pmid': '20651055', 'type': 'BACKGROUND', '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.'}, {'pmid': '12920151', 'type': 'BACKGROUND', '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. doi: 10.1210/er.2002-0025.'}]}, 'descriptionModule': {'briefSummary': 'Study on the Carcinogenesis of SOX-9 in Oral Cancer, and Chemopreventive Possibility for the Treatment of Oral Cancer Using SOX-9 Inhibitor.', 'detailedDescription': '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.\n\nWe 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.\n\nWe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Medical center', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Dysplasia or cancer of the oral cavity.\n\nExclusion Criteria:\n\n* pregnant woman'}, 'identificationModule': {'nctId': 'NCT01919567', 'briefTitle': 'Study on the Carcinogenesis of SOX-9 in Oral Cancer, and Chemopreventive Possibility for the Treatment of Oral Cancer.', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'Observational Study on the Carcinogenesis of SOX-9 in Oral Cancer, and Chemopreventive Possibility for the Treatment of Oral Cancer Using SOX-9 Inhibitor.', 'orgStudyIdInfo': {'id': '201012095RC'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Normal team', 'description': "Subjects who have problem at third molar of impacted tooth need to receive a surgery with general anesthesia.\n\nSubjects must:\n\nShould have a blood exam (20ml) before the surgery.\n\nSite staff must:\n\nCollect subjects' saliva once a day (in the morning before breakfast) for 3 consecutive days.\n\nCollect a 0.5x0.5Cm2 tissue sample around third molar during the surgery."}, {'label': 'Oral dysplasia', 'description': 'Subjects who are diagnosed with dysplasia of oral cavity.\n\nSubjects must:\n\nShould have a blood exam (20ml/each time) before the surgery and 3 months after the surgery.\n\nIn 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.\n\nBefore the surgery site staff must:\n\nCollect saliva once a day (in the morning before breakfast) for 3 consecutive days.\n\nCollect a 0.5x0.5Cm2 tissue sample of the tumor during the surgery.'}, {'label': 'Oral cancer', 'description': "Subjects who suffer from oral cancer.\n\nSubjects must:\n\nShould have a blood exam (20ml/each time) before the surgery and 3 months after the surgery.\n\nIn 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.\n\nBefore the surgery site staff must:\n\nCollect subjects' saliva once a day (in the morning before breakfast) for 3 consecutive days.\n\nCollect a 0.5x0.5Cm2 tissue sample of the tumor during the surgery."}]}, 'contactsLocationsModule': {'locations': [{'zip': '10048', 'city': 'Taipei', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Shin-Jung Cheng, DDS, MS, PhD', 'role': 'CONTACT', 'email': 'sjcheng56@ntu.edu.tw', 'phone': '+886 2 29251733', 'phoneExt': '67509'}, {'name': 'Shin-Jung Cheng, DDS, MS, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'National Taiwan University Hospital research Ethics Committee', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'centralContacts': [{'name': 'Shin-Jung Cheng, DDS, MS, PhD', 'role': 'CONTACT', 'email': 'sjcheng56@ntu.edu.tw', 'phone': '+886 2 29251733', 'phoneExt': '67509'}], 'overallOfficials': [{'name': 'Shin-Jung Cheng, DDS, MS, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}