A Study on the Long Term Survivals in an Expand Access Program (EAP) of Iressa
NCT ID: NCT01000740
Last Updated: 2010-05-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
59 participants
INTERVENTIONAL
2009-08-31
2010-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
Long term survivors who has been used IRESSA for more than 3 years and are still on gefitinib treatment
EGFR Mutation Test
Explore the EGFR mutation status from both tumour tissue sample and the free DNA in the peripheral blood using appropriate method(s) which may include ARMS assay, ME-PCR coupled sequencing and regular sequencing.
Ki-67 protein expression
Ki-67 protein expression in tissue will be analysed by IHC method.
2
Long term survivors who has been used IRESSA for more than 3 years but have already terminated from EAP
No interventions assigned to this group
3
Fast-progressors who defined as no more than 1 follow-up visit after recruitment with the reason of discontinuation being
No interventions assigned to this group
Interventions
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EGFR Mutation Test
Explore the EGFR mutation status from both tumour tissue sample and the free DNA in the peripheral blood using appropriate method(s) which may include ARMS assay, ME-PCR coupled sequencing and regular sequencing.
Ki-67 protein expression
Ki-67 protein expression in tissue will be analysed by IHC method.
Eligibility Criteria
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Inclusion Criteria
* Participated in the Iressa EAP in China.
* Diagnosed as NSCLC.
* Patients who started EAP at least 3 years before this study initiated and have not yet terminated from the EAP (active long-term survivors).
* Patients who consent to provide blood sample and available archival tumour tissue sample for EGFR gene testing (provision of tumour tissue sample is optional).
Exclusion Criteria
* Patients in whose medical objection was recorded to use the existing data from medical practice for scientific research.
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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AstraZeneca China
Principal Investigators
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Karen Atkin
Role: STUDY_DIRECTOR
AstraZeneca
Louis Zhang
Role: STUDY_CHAIR
AstraZeneca
Longyun Li
Role: PRINCIPAL_INVESTIGATOR
Peking Union Medical College Hospital
Locations
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Research Site
Beijing, Beijing Municipality, China
Research Site
Guangzhou, Guangdong, China
Research Site
Wuhan, Hubei, China
Research Site
Nanjing, Jiangsu, China
Research Site
Suzhou, Jiangsu, China
Research Site
Jinan, Shandong, China
Research Site
Shanghai, Shanghai Municipality, China
Research Site
Chengdu, Sichuan, China
Research Site
Hangzhou, Zhejiang, China
Countries
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References
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Li L, Zhong W, Liao M, Chen L, Han B, Guan Z, Yu S, Liu X, Wu Y, Jiang G, Xu J, Chen J, Tao M, Luo R, Li W, Xu N, Zhao X, Wang M. [A study on the long-term non-small cell lung cancer survivors in the Expand Access Program of gefitinib in China]. Zhongguo Fei Ai Za Zhi. 2012 Jun;15(6):332-9. doi: 10.3779/j.issn.1009-3419.2012.06.03. Chinese.
Other Identifiers
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1839IL/0052 SubStudy
Identifier Type: -
Identifier Source: org_study_id
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