Ignite Creation Date:
2025-12-24 @ 3:03 PM
Ignite Modification Date:
2025-12-25 @ 1:26 PM
Study NCT ID:
NCT01255059
Status:
UNKNOWN
Last Update Posted:
2015-12-22
First Post:
2010-12-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
GWAS Research of Lung Cancer in Tianjin
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Peripheral blood sample (10 ml) was collected from each study subject. Buffy coats were isolated and frozen for DNA extraction.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-01', 'completionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-12-21', 'studyFirstSubmitDate': '2010-12-05', 'studyFirstSubmitQcDate': '2010-12-05', 'lastUpdatePostDateStruct': {'date': '2015-12-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-12-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Genetic variant in TP63 on locus 3q28 is associated with risk of lung adenocarcinoma among never-smoking females in Asia', 'timeFrame': '2011-12', 'description': 'A GWAS reported a novel association between the TP63 locus and risk of lung adenocarcinoma; however, this association did not achieve genome-wide significance among never-smoking males or females. We genotyped the TP63 SNPs reported by the previous GWAS (rs10937405 and rs4488809) in 500 never-smoking female lung cancer cases and 500 never-smoking female controls from China. Genetic variation in rs10937405 was associated with lung adenocarcinoma. Our findings provide strong evidence that genetic variation in TP63 is associated with risk of lung adenocarcinoma among non-smoking females.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Genome-wide association studies(GWAS)', 'Single nucleotide polymorphism(SNP)', 'Lung cancer'], 'conditions': ['Non-small Cell Lung Cancer', 'Primary Carcinoma']}, 'referencesModule': {'references': [{'pmid': '19836008', 'type': 'BACKGROUND', 'citation': 'Landi MT, Chatterjee N, Yu K, Goldin LR, Goldstein AM, Rotunno M, Mirabello L, Jacobs K, Wheeler W, Yeager M, Bergen AW, Li Q, Consonni D, Pesatori AC, Wacholder S, Thun M, Diver R, Oken M, Virtamo J, Albanes D, Wang Z, Burdette L, Doheny KF, Pugh EW, Laurie C, Brennan P, Hung R, Gaborieau V, McKay JD, Lathrop M, McLaughlin J, Wang Y, Tsao MS, Spitz MR, Wang Y, Krokan H, Vatten L, Skorpen F, Arnesen E, Benhamou S, Bouchard C, Metspalu A, Metsapalu A, Vooder T, Nelis M, Valk K, Field JK, Chen C, Goodman G, Sulem P, Thorleifsson G, Rafnar T, Eisen T, Sauter W, Rosenberger A, Bickeboller H, Risch A, Chang-Claude J, Wichmann HE, Stefansson K, Houlston R, Amos CI, Fraumeni JF Jr, Savage SA, Bertazzi PA, Tucker MA, Chanock S, Caporaso NE. A genome-wide association study of lung cancer identifies a region of chromosome 5p15 associated with risk for adenocarcinoma. Am J Hum Genet. 2009 Nov;85(5):679-91. doi: 10.1016/j.ajhg.2009.09.012. Epub 2009 Oct 15.'}, {'pmid': '19247474', 'type': 'BACKGROUND', 'citation': 'Caporaso N, Gu F, Chatterjee N, Sheng-Chih J, Yu K, Yeager M, Chen C, Jacobs K, Wheeler W, Landi MT, Ziegler RG, Hunter DJ, Chanock S, Hankinson S, Kraft P, Bergen AW. Genome-wide and candidate gene association study of cigarette smoking behaviors. PLoS One. 2009;4(2):e4653. doi: 10.1371/journal.pone.0004653. Epub 2009 Feb 27.'}, {'pmid': '20876614', 'type': 'BACKGROUND', 'citation': 'Yoon KA, Park JH, Han J, Park S, Lee GK, Han JY, Zo JI, Kim J, Lee JE, Takahashi A, Kubo M, Nakamura Y, Lee JS. A genome-wide association study reveals susceptibility variants for non-small cell lung cancer in the Korean population. Hum Mol Genet. 2010 Dec 15;19(24):4948-54. doi: 10.1093/hmg/ddq421. Epub 2010 Sep 28.'}, {'pmid': '21303977', 'type': 'BACKGROUND', 'citation': 'Rafnar T, Sulem P, Besenbacher S, Gudbjartsson DF, Zanon C, Gudmundsson J, Stacey SN, Kostic JP, Thorgeirsson TE, Thorleifsson G, Bjarnason H, Skuladottir H, Gudbjartsson T, Isaksson HJ, Isla D, Murillo L, Garcia-Prats MD, Panadero A, Aben KK, Vermeulen SH, van der Heijden HF, Feser WJ, Miller YE, Bunn PA, Kong A, Wolf HJ, Franklin WA, Mayordomo JI, Kiemeney LA, Jonsson S, Thorsteinsdottir U, Stefansson K. Genome-wide significant association between a sequence variant at 15q15.2 and lung cancer risk. Cancer Res. 2011 Feb 15;71(4):1356-61. doi: 10.1158/0008-5472.CAN-10-2852. Epub 2011 Feb 8.'}]}, 'descriptionModule': {'briefSummary': 'To study the association of Genetic Polymorphisms with Lung Cancer Risk in Tianjin Population.', 'detailedDescription': 'Eligibility criteria:\n\n* nonsmoker\n* female\n* age between 35 and 80\n* no other types of tumors history\n* frequency-matched cases and controls on gender and age\n\nOutcome measures:\n\n* OR(odds ratio)\n* RR(risk ratio)\n* CI(confidence interval)\n* SAS software'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '35 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients were newly diagnosed and histologically confirmed primary non-small cell lung cancer from Tianjin Medical University Cancer Hospital.The control subjects who underwent health check-up in hospitals were frequency-matched to cases on gender and age. All the subjects were genetically unrelated Chinese with Han ethnicity.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Non-small cell lung cancer\n* Age from 35 to 80 years old\n* Female\n* Non-smokers\n* Frequency-matched on age and gender\n\nExclusion Criteria:\n\n* Previous medical history of cancer\n* Previous radiotherapy\n* Previous chemotherapy'}, 'identificationModule': {'nctId': 'NCT01255059', 'briefTitle': 'GWAS Research of Lung Cancer in Tianjin', 'organization': {'class': 'OTHER', 'fullName': 'Tianjin Medical University Cancer Institute and Hospital'}, 'officialTitle': 'GWAS Research of Lung Cancer by Department of Epidemiology and Biostatistics in Tianjin Medical University Cancer Institute and Hospital', 'orgStudyIdInfo': {'id': 'TMU-CIH-GWASLC-Epi-Tianjin'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Female lung cancer group', 'description': 'Female, non-smoker, non-small cell lung cancer'}, {'label': 'Health control', 'description': "Female, non-smokers, no lung cancer or other types of cancers' healthy population"}]}, 'contactsLocationsModule': {'locations': [{'zip': '300060', 'city': 'Tianjin', 'state': 'Tianjin Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Chen Kexin, M.D., Ph.D', 'role': 'CONTACT', 'email': 'chenkexin1963@yahoo.com', 'phone': '0086-022-23372231'}, {'name': 'Chen Kexin, M.D., Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Tianjin Medical University Cancer Institute and Hospital', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}], 'centralContacts': [{'name': 'Chen Kexin, M.D., Ph.D', 'role': 'CONTACT', 'email': 'chenkexin1963@yahoo.com', 'phone': '0086-022-23372231'}], 'overallOfficials': [{'name': 'Chen Kexin, M.D., Ph.D', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Tianjin Medical University Cancer Institute and Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tianjin Medical University Cancer Institute and Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}