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The primary objective is to describe the quality of life of long-term survivors who are not terminated from the EAP.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Long term survivors who has been used IRESSA for more than 3 years and are still on gefitinib treatment |
|
| 2 | No Intervention | Long term survivors who has been used IRESSA for more than 3 years but have already terminated from EAP | |
| 3 | No Intervention | Fast-progressors who defined as no more than 1 follow-up visit after recruitment with the reason of discontinuation being |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EGFR Mutation Test | Genetic | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Describe the quality of life of long-term survivors who are not terminated from the EAP |
| Measure | Description | Time Frame |
|---|---|---|
| To describe the current tumour control status via RECIST | ||
| To collect the risk factors related to prognosis in addition to the information already collected from EAP (age, gender, histology, smoking history, previous history of anti-cancer treatment, disease stage before starting gefitinib treatment, etc.) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karen Atkin | AstraZeneca | Study Director |
| Louis Zhang | AstraZeneca | Study Chair |
| Longyun Li | Peking Union Medical College Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Beijing | Beijing Municipality | China | |||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22681919 | Derived | 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. |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| Ki-67 protein expression | Genetic | Ki-67 protein expression in tissue will be analysed by IHC method. |
|
| To describe the treatment compliance of gefitinib in these patients |
| To describe the current clinical status of long-term survivors in the EAP program by clinical |
| To compare the key clinical features (age group, gender, histology, smoking history, disease stage, treatment-naive or pre-treated, response to prior chemotherapy,) in fast-progressors versus long-term survivals. |
| 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 |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |