NCT01106781

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
591

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2010

Typical duration for all trials

Geographic Reach
1 country

13 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 14, 2010

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 20, 2010

Completed
3 months until next milestone

Study Start

First participant enrolled

August 1, 2010

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

March 18, 2014

Status Verified

March 1, 2014

Enrollment Period

3.4 years

First QC Date

April 14, 2010

Last Update Submit

March 17, 2014

Conditions

Keywords

EGFR mutation testNSCLCNon-Interventional StudyEGFR mutation status

Outcome Measures

Primary Outcomes (1)

  • type and prevalence of EGFR mutation

    up to 3 months

Secondary Outcomes (2)

  • Operation type and adjuvant treatment type

    up to 3 months

  • Disease Free Survival rate

    up to 3 months

Study Arms (1)

1

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients from Thoracic surgery department

You may qualify if:

  • 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

You may not qualify if:

  • Patients who disagree to participate this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Research Site

Beijing, Beijing Municipality, China

Location

Research Site

Chongqing, Chongqing Municipality, China

Location

Research Site

Guangzhou, Guangdong, China

Location

Research Site

Wuhan, Hubei, China

Location

Research Site

Nanjing, Jiangsu, China

Location

Research Site

Suzhou, Jiangsu, China

Location

Research Site

Changchun, Jilin, China

Location

Research Site

Shenyang, Liaoning, China

Location

Research Site

Qingdao, Shandong, China

Location

Research Site

Shanghai, Shanghai Municipality, China

Location

Research Site

Chengdu, Sichuan, China

Location

Research Site

Tianjin, Tianjin Municipality, China

Location

Research Site

Hangzhou, Zhejiang, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Karen Atkin

    Astrazeneca China R&D

    STUDY DIRECTOR
  • Wu Yilong

    Guangdong Provincial People's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 14, 2010

First Posted

April 20, 2010

Study Start

August 1, 2010

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

March 18, 2014

Record last verified: 2014-03

Locations