NCT02975752

Brief Summary

First-line treatment with afatinib prolongs overall survival in patients with metastatic non-small-cell lung cancer (NSCLC) harboring EGFR exon 19 deletion mutations. Conversely, somatic KRAS mutations are negative predictors for benefit from EGFR-targeting agents. In this study we want to compare a new highly sensitive method for the detection of EGFRdelEx19 and KRAS Exon 2 with targeted-resequencing multiplex-PCR (NGS).

Trial Health

100
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2015

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

March 1, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

November 23, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 29, 2016

Completed
Last Updated

November 29, 2016

Status Verified

November 1, 2016

Enrollment Period

1.3 years

First QC Date

November 23, 2016

Last Update Submit

November 23, 2016

Conditions

Lung Adenocarcinoma Metastatic

Outcome Measures

Primary Outcomes (1)

  • detection of mutations

    1 year

Interventions

LC-RT-PCR and NGSGENETIC

highly sensitive PCR vs. multiplex targeted-resequencing

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with suspected lung cancer on the chest CT-scan images receiving EBUS-TBNA (endobronchial ultrasound-guided transbronchial needle aspiration) for clinical pre-treatment workup of mediastinal and hilar lymph nodes

You may qualify if:

  • lung adenocarcinoma positive EBUS-TBNA specimen

You may not qualify if:

  • other diagnosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITH DNA

EBUS-TBNA specimen of lymph nodes and primary tumor

Study Officials

  • Filiz Özkan, MD

    Department of Interventional Pneumology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. med. Filiz Özkan

Study Record Dates

First Submitted

November 23, 2016

First Posted

November 29, 2016

Study Start

March 1, 2015

Primary Completion

June 1, 2016

Study Completion

November 1, 2016

Last Updated

November 29, 2016

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will not share