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 has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01106781
First received: April 14, 2010
Last updated: March 17, 2014
Last verified: March 2014
  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: 591
Study Start Date: August 2010
Study Completion Date: January 2014
Primary Completion Date: January 2014 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: March 17, 2014
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:
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
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 19, 2014