GWAS Research of Lung Cancer in Tianjin

Non-small Cell Lung Cancer Clinical Trial

Official title:

GWAS Research of Lung Cancer by Department of Epidemiology and Biostatistics in Tianjin Medical University Cancer Institute and Hospital

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01255059
• Other study ID #: TMU-CIH-GWASLC-Epi-Tianjin
• Status: Recruiting
• Phase: N/A
• First received: December 5, 2010
• Last updated: December 21, 2015
• Start date: June 2010
• Est. completion date: December 2016

Study information

• Verified date: January 2012
• Source: Tianjin Medical University Cancer Institute and Hospital
• Contact: Chen Kexin, M.D., Ph.D
• Phone: 0086-022-23372231
• Email: chenkexin1963[@]yahoo.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Observational

Clinical Trial Summary

To study the association of Genetic Polymorphisms with Lung Cancer Risk in Tianjin Population.

Description:

Eligibility criteria:

• nonsmoker

• female

• age between 35 and 80

• no other types of tumors history

• frequency-matched cases and controls on gender and age

Outcome measures:

• OR(odds ratio)

• RR(risk ratio)

• CI(confidence interval)

• SAS software

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 35 Years to 80 Years

Eligibility

Inclusion Criteria:

• Non-small cell lung cancer

• Age from 35 to 80 years old

• Female

• Non-smokers

• Frequency-matched on age and gender

Exclusion Criteria:

• Previous medical history of cancer

• Previous radiotherapy

• Previous chemotherapy

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer
• Primary Carcinoma

Locations

Country	Name	City	State
China	Tianjin Medical University Cancer Institute and Hospital	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin Medical University Cancer Institute and Hospital

Country where clinical trial is conducted

China, 

References & Publications (4)

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. — View 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, Vooder T, Nelis M, Välk K, Field JK, Chen C, Goodman G, Sulem P, Thorleifsson G, Rafnar T, Eisen T, Sauter W, Rosenberger A, Bickeböller 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. Erratum in: Am J Hum Genet. 2011 Jun 10;88(6):861. Metsapalu, Andres [corrected to Metspalu, Andres]. — View 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, García-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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Genetic variant in TP63 on locus 3q28 is associated with risk of lung adenocarcinoma among never-smoking females in Asia	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.	2011-12	Yes