Non-small Cell Lung CancerNCT01255059
GWAS Research of Lung Cancer in Tianjin
An observational study of Non-small Cell Lung Cancer and Primary Carcinoma, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial summary
To study the association of Genetic Polymorphisms with Lung Cancer Risk in Tianjin Population. Read more about this study
- Who is it for?
- Ages 35 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Non-small Cell Lung Cancer, Primary Carcinoma
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- Jun 2010to Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Non-small cell lung cancer
- Age from 35 to 80 years old
- Female
- Non-smokers
- Frequency-matched on age and gender
Who cannot join
- Previous medical history of cancer
- Previous radiotherapy
- Previous chemotherapy
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300060
Chen Kexin, M.D., Ph.D, 0086-022-23372231, chenkexin1963@yahoo.com
Chen Kexin, M.D., Ph.D
About this study
Official title: GWAS Research of Lung Cancer by Department of Epidemiology and Biostatistics in Tianjin Medical University Cancer Institute and Hospital
To study the association of Genetic Polymorphisms with Lung Cancer Risk in Tianjin Population.
Read the 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
- Conditions
- Non-small Cell Lung Cancer, Primary Carcinoma
- Keywords
- Genome-wide association studies(GWAS), Single nucleotide polymorphism(SNP), Lung cancer
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2011-12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2010 (estimated)
- Study startJun 2010
- Primary completionNov 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chen Kexin, M.D., Ph.D, Study director, Tianjin Medical University Cancer Institute and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01255059
- Sponsor's protocol ID
- TMU-CIH-GWASLC-Epi-Tianjin
- Status last verified
- Jan 2012
- First submitted
- 5 Dec 2010
- Last updated
- 22 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
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, 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.
PubMed 19836008Caporaso 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.
PubMed 19247474Yoon 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.
PubMed 20876614Rafnar 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.
PubMed 21303977
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GWAS Research of Lung Cancer by Department of Epidemiology and Biostatistics in Tianjin Medical University Cancer Institute and Hospital
- ClinicalTrials.gov ID
- NCT01255059
- Acronym / sponsor ID
- TMU-CIH-GWASLC-Epi-Tianjin
- Conditions
- Non-small Cell Lung Cancer, Primary Carcinoma
- Keywords
- Genome-wide association studies(GWAS), Single nucleotide polymorphism(SNP), Lung cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Nov 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 7 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To study the association of Genetic Polymorphisms with Lung Cancer Risk in Tianjin 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
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 35 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- Non-small cell lung cancer
- Age from 35 to 80 years old
- Female
- Non-smokers
- Frequency-matched on age and gender
Key exclusion criteria (3 listed)
- Previous medical history of cancer
- Previous radiotherapy
- Previous chemotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Genetic variant in TP63 on locus 3q28 is associated with risk of lung adenocarcinoma among never-smoking females in Asia
Time frame: 2011-12
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2015.
- Background: PubMed 19836008Landi 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.
- Background: PubMed 19247474Caporaso 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.
- Background: PubMed 20876614Yoon 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.
- Background: PubMed 21303977Rafnar 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chen Kexin, M.D., Ph.D study director
Tianjin Medical University Cancer Institute and Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-small Cell Lung Cancer and Primary Carcinoma, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chen Kexin, M.D., Ph.D (0086-022-23372231, chenkexin1963@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Genetic variant in TP63 on locus 3q28 is associated with risk of lung adenocarcinoma among never-smoking females in Asia (time frame: 2011-12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01255059, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2015.