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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)

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ClinicalTrials.gov Identifier: NCT01106781
Recruitment Status : Completed
First Posted : April 20, 2010
Last Update Posted : March 18, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease
Non-Small Cell Lung Cancer

Study Design

Study Type : Observational
Actual Enrollment : 591 participants
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
Study Start Date : August 2010
Primary Completion Date : January 2014
Study Completion Date : January 2014

Resource links provided by the National Library of Medicine

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

Groups and Cohorts

Group/Cohort
1
Patients in this group should be histological confirmed adenocarcinoma of the lung, have received complete resection and tested for EGFR mutation.


Outcome Measures

Primary Outcome Measures :
  1. type and prevalence of EGFR mutation [ Time Frame: up to 3 months ]

Secondary Outcome Measures :
  1. Operation type and adjuvant treatment type [ Time Frame: up to 3 months ]
  2. Disease Free Survival rate [ Time Frame: up to 3 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01106781     History of Changes
Other Study ID Numbers: NIS-OCN-DUM-2009/1
First Posted: April 20, 2010    Key Record Dates
Last Update Posted: March 18, 2014
Last Verified: March 2014

Keywords provided by AstraZeneca:
EGFR mutation test
NSCLC
Non-Interventional Study
EGFR mutation status

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Adenocarcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Mitogens
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action