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GWAS Research of Lung Cancer in Tianjin

This study is currently recruiting participants.
Verified January 2012 by Tianjin Medical University Cancer Institute and Hospital
Sponsor:
Information provided by (Responsible Party):
Kexin Chen, Tianjin Medical University Cancer Institute and Hospital
ClinicalTrials.gov Identifier:
NCT01255059
First received: December 5, 2010
Last updated: January 12, 2012
Last verified: January 2012
History of Changes
  Purpose

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


Condition
Non-small Cell Lung Cancer
Primary Carcinoma

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: GWAS Research of Lung Cancer by Department of Epidemiology and Biostatistics in Tianjin Medical University Cancer Institute and Hospital

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer
U.S. FDA Resources

Further study details as provided by Tianjin Medical University Cancer Institute and Hospital:

Primary Outcome Measures:
  • Genetic variant in TP63 on locus 3q28 is associated with risk of lung adenocarcinoma among never-smoking females in Asia [ Time Frame: 2011-12 ] [ Designated as safety issue: Yes ]
    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.


Biospecimen Retention:   Samples With DNA

Peripheral blood sample (10 ml) was collected from each study subject. Buffy coats were isolated and frozen for DNA extraction.


Estimated Enrollment: 500
Study Start Date: June 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Female lung cancer group
Female, non-smoker, non-small cell lung cancer
Health control
Female, non-smokers, no lung cancer or other types of cancers` healthy population

Detailed 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
  Eligibility

Ages Eligible for Study:   35 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01255059

Contacts
Contact: Chen Kexin, M.D., Ph.D 0086-022-23372231 chenkexin1963@yahoo.com

Locations
China, Tianjin
Tianjin Medical University Cancer Institute and Hospital Recruiting
Tianjin, Tianjin, China, 300060
Contact: Chen Kexin, M.D., Ph.D     0086-022-23372231     chenkexin1963@yahoo.com    
Principal Investigator: Chen Kexin, M.D., Ph.D            
Sponsors and Collaborators
Tianjin Medical University Cancer Institute and Hospital
Investigators
Study Director: Chen Kexin, M.D., Ph.D Tianjin Medical University Cancer Institute and Hospital
  More Information

Publications:
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, Metsapalu 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. Epub 2009 Oct 15.

Responsible Party: Kexin Chen, Department of Epidemiology and Biostatistics, Tissue Bank Facility, Tianjin Medical University Cancer Institute and Hospital
ClinicalTrials.gov Identifier: NCT01255059     History of Changes
Other Study ID Numbers: TMU-CIH-GWASLC-Epi-Tianjin
Study First Received: December 5, 2010
Last Updated: January 12, 2012
Health Authority: China: Ethics Committee

Keywords provided by Tianjin Medical University Cancer Institute and Hospital:
Genome-wide association studies(GWAS)
Single nucleotide polymorphism(SNP)
Lung cancer

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carcinoma, Bronchogenic
 Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 16, 2013