NCT03171636

Brief Summary

The assessment of the type and frequency of EGFR and KRAS mutations in lung cancer patients, as well as clinical-prognostic correlation, are crucial in the era of targeted therapies. EGFR-activating mutations predict responsiveness to EGFR tyrosine kinase inhibitors (TKIs) in non-small cell lung cancer (NSCLC) patients and KRAS analysis will be useful in a near future for newest target drugs. In Brazil, few data about the prevalence of EGFR and KRAS mutations is available and their knowledge would allow optimize personalized medicine.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
130

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

April 1, 2014

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

May 26, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 31, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

February 22, 2019

Status Verified

February 1, 2019

Enrollment Period

3.4 years

First QC Date

May 26, 2017

Last Update Submit

February 20, 2019

Conditions

Lung NeoplasmsKRAS Gene MutationEGFR Gene Mutation

Outcome Measures

Primary Outcomes (2)

  • EGRF mutation status

    results of presence or absence in all tumor samples (FFPE) obtained from patients

    3 years

  • KRAS mutation status

    results of presence or absence in all tumor samples (FFPE) obtained from patients

    3 years

Eligibility Criteria

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

From 237 patients with NSCLC treated at Erasto Gaertner Cancer Hospital, the largest reference cancer hospital in the Southern Brazil, from January 2005 to January 2017, we could select 130 FFPE specimens stored at the Pathology Department.

You may qualify if:

  • Brazilian patients with metastatic non-small cell lung cancer.

You may not qualify if:

  • Small cell lung cancer and non-metastatic patients.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Erasto Gaertner

Curitiba, Paraná, 81520-060, Brazil

Location

Biospecimen

Retention: SAMPLES WITH DNA

DNA sample from formalin-fixed paraffin-embedded (FFPE) tissue.

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Thais A Almeida, MD

    Liga Paranaense de Combate ao Cancer

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

May 26, 2017

First Posted

May 31, 2017

Study Start

April 1, 2014

Primary Completion

September 1, 2017

Study Completion

January 1, 2019

Last Updated

February 22, 2019

Record last verified: 2019-02

Locations

BR(1)