A Non-interventional Survey on the EGFR (Epidermal Growth Factor Receptor) Mutation Status in Completely Resected Chinese Non-Small Cell Lung Cancer (NSCLC) Patients With Adenocarcinoma Histology (ICAN)
This study is ongoing, but not recruiting participants.
Sponsor:
AstraZeneca
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01106781
First received: April 14, 2010
Last updated: June 12, 2013
Last verified: June 2013
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Purpose
This is a descriptive observational study. The primary objective is to explore the EGFR gene mutation status in early stage NSCLC with adenocarcinoma histology after complete resection. The patients should be histological confirmed adenocarcinoma of the lung, have received complete resection and tested for EGFR mutation in regular medical practice.
| Condition |
|---|
|
Non-Small Cell Lung Cancer |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | A Non-interventional Survey on the Epidermal Growth Factor Receptor (EGFR) Mutation Status in Completely Resected Chinese Non-Small Cell Lung Cancer (NSCLC) Patients With Adenocarcinoma Histology |
Resource links provided by NLM:
Further study details as provided by AstraZeneca:
Primary Outcome Measures:
- type and prevalence of EGFR mutation [ Time Frame: up to 3 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Operation type and adjuvant treatment type [ Time Frame: up to 3 months ] [ Designated as safety issue: No ]
- Disease Free Survival rate [ Time Frame: up to 3 months ] [ Designated as safety issue: No ]
| Enrollment: | 610 |
| Study Start Date: | August 2010 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
1
Patients in this group should be histological confirmed adenocarcinoma of the lung, have received complete resection and tested for EGFR mutation.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Patients from Thoracic surgery department
Criteria
Inclusion Criteria:
- Histological diagnosed as adenocarcinoma type of non-small cell lung cancer
- Have completed lung cancer operation
- The tumour EGFR gene mutation status test was performed as regular medical practice
Exclusion Criteria:
- Patients who disagree to participate this study
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01106781
Locations
| China, Beijing | |
| Research Site | |
| Beijing, Beijing, China | |
| China, Chongqing | |
| Research Site | |
| Chongqing, Chongqing, China | |
| China, Guangdong | |
| Research Site | |
| Guangzhou, Guangdong, China | |
| China, Hubei | |
| Research Site | |
| Wuhan, Hubei, China | |
| China, Jiangsu | |
| Research Site | |
| Nanjing, Jiangsu, China | |
| Research Site | |
| Suzhou, Jiangsu, China | |
| China, Jilin | |
| Research Site | |
| Changchun, Jilin, China | |
| China, Liaoning | |
| Research Site | |
| Shenyang, Liaoning, China | |
| China, Shandong | |
| Research Site | |
| Qingdao, Shandong, China | |
| China, Shanghai | |
| Research Site | |
| Shanghai, Shanghai, China | |
| China, Sichuan | |
| Research Site | |
| Chengdu, Sichuan, China | |
| China, Tianjin | |
| Research Site | |
| Tianjin, Tianjin, China | |
| China, Zhejiang | |
| Research Site | |
| Hangzhou, Zhejiang, China | |
Sponsors and Collaborators
AstraZeneca
Investigators
| Study Director: | Karen Atkin | Astrazeneca China R&D |
| Principal Investigator: | Wu Yilong | Guangdong General Hospital |
More Information
No publications provided
| Responsible Party: | AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT01106781 History of Changes |
| Other Study ID Numbers: | NIS-OCN-DUM-2009/1 |
| Study First Received: | April 14, 2010 |
| Last Updated: | June 12, 2013 |
| Health Authority: | China: Food and Drug Administration |
Keywords provided by AstraZeneca:
|
EGFR mutation test NSCLC Non-Interventional Study EGFR mutation status |
Additional relevant MeSH terms:
|
Adenocarcinoma Adenocarcinoma, Mucinous Carcinoma, Non-Small-Cell Lung Lung Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Cystic, Mucinous, and Serous Carcinoma, Bronchogenic |
Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Lung Diseases Respiratory Tract Diseases Mitogens Mitosis Modulators Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 17, 2013