NCT01100827

Brief Summary

To determine EGFR mutation status in patients with advanced stage adenocarcinoma NSCLC. To determine the association between EGFR mutation status and demographic data in advanced stage adenocarcinoma NSCLC patients.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Feb 2013

Geographic Reach
1 country

1 active site

Status
unknown

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 7, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 9, 2010

Completed
2.8 years until next milestone

Study Start

First participant enrolled

February 1, 2013

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

December 11, 2013

Status Verified

December 1, 2013

Enrollment Period

2 years

First QC Date

April 7, 2010

Last Update Submit

December 10, 2013

Conditions

NSCLC

Keywords

EGFR mutation status in patients with advanced stage adenocarcinoma NSCLCThe association between EGFR mutation status and demographic data in advanced stage adenocarcinoma NSCLC patients.

Study Arms (1)

EGFR mutation status in patients

Other: EGFR mutation status in patients

Interventions

EGFR mutation status in patientsOTHER
EGFR mutation status in patients

Eligibility Criteria

Age1 Year+
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

In order to determine the EGFR mutation status, data analysis will be performed on demographic data and medical records (i.e. case notes and pathology reports) from patient with advanced stage adenocarcinoma NSCLC

You may qualify if:

  • Nil

You may not qualify if:

  • Nil

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National University Hospital Singapore

Singapore, Singapore, Singapore

RECRUITING

Related Publications (2)

  • Shigematsu H, Lin L, Takahashi T, Nomura M, Suzuki M, Wistuba II, Fong KM, Lee H, Toyooka S, Shimizu N, Fujisawa T, Feng Z, Roth JA, Herz J, Minna JD, Gazdar AF. Clinical and biological features associated with epidermal growth factor receptor gene mutations in lung cancers. J Natl Cancer Inst. 2005 Mar 2;97(5):339-46. doi: 10.1093/jnci/dji055.

    PMID: 15741570BACKGROUND

  • Miller VA, Kris MG, Shah N, Patel J, Azzoli C, Gomez J, Krug LM, Pao W, Rizvi N, Pizzo B, Tyson L, Venkatraman E, Ben-Porat L, Memoli N, Zakowski M, Rusch V, Heelan RT. Bronchioloalveolar pathologic subtype and smoking history predict sensitivity to gefitinib in advanced non-small-cell lung cancer. J Clin Oncol. 2004 Mar 15;22(6):1103-9. doi: 10.1200/JCO.2004.08.158.

    PMID: 15020612BACKGROUND

Central Study Contacts

Ross Andrew Soo, MBBS

CONTACT

65 6772 4624ross_soo@nuhs.edu.sg

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 7, 2010

First Posted

April 9, 2010

Study Start

February 1, 2013

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

December 11, 2013

Record last verified: 2013-12

Locations

SG(1)