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

Non-Small Cell Lung Cancer Clinical Trial

— ICAN  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01106781
• Other study ID #: NIS-OCN-DUM-2009/1
• Status: Completed
• Phase: N/A
• First received: April 14, 2010
• Last updated: March 17, 2014
• Start date: August 2010
• Est. completion date: January 2014

Study information

• Verified date: March 2014
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 591
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Adenocarcinoma
• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small Cell Lung Cancer

Locations

Country	Name	City	State
China	Research Site	Beijing	Beijing
China	Research Site	Changchun	Jilin
China	Research Site	Chengdu	Sichuan
China	Research Site	Chongqing	Chongqing
China	Research Site	Guangzhou	Guangdong
China	Research Site	Hangzhou	Zhejiang
China	Research Site	Nanjing	Jiangsu
China	Research Site	Qingdao	Shandong
China	Research Site	Shanghai	Shanghai
China	Research Site	Shenyang	Liaoning
China	Research Site	Suzhou	Jiangsu
China	Research Site	Tianjin	Tianjin
China	Research Site	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	type and prevalence of EGFR mutation		up to 3 months	No
Secondary	Operation type and adjuvant treatment type		up to 3 months	No
Secondary	Disease Free Survival rate		up to 3 months	No