EGFR Mutations on ctDNA in Patients With Advanced NSCLC

February 12, 2018 updated by: First People's Hospital of Hangzhou

A Diagnostic Study to Determine the Prevalence of Epidermal Growth Factor Receptor Mutations Assessed With Circulating Tumor DNA Samples in Advanced Non-small Cell Lung Cancer

The study aims to explore the prevalence of EGFR mutations assessed with ctDNA samples in advanced NSCLC, who had received ≤ 1 prior systemic chemotherapy regimens.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1055

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310006
        • Hangzhou First People's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with Non-small cell lung cancer (NSCLC)

Description

Inclusion Criteria:

  • Histologically confirmed stage IIIB/IV NSCLC;
  • Patient had received ≤ 1 prior systemic chemotherapy regimens;
  • Provision of blood (plasma) sample for ctDNA testing;
  • Patient must be able to comply with the protocol;

Exclusion Criteria:

  • Prior received ≥2 systemic chemotherapy regimens;
  • As judged by the investigator, any evidence of severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease);
  • Histologically confirmed small cell lung cancer or other metastatic tumors;
  • Patient with no histologic or cytological diagnosis;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients with EGFR mutation detected by amplification refractory mutation system (ARMS) assay
Time Frame: up to 2 years
The investigators will describe the proportion of EGFR mutation on ctDNA detected by ARMS assay in patients with non-small cell lung cancer (NSCLC)
up to 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Distribution of EGFR mutation by ARMS assays among the different Clinical characteristics
Time Frame: up to 2 years
The investigators will employ chi-square test to analyze the distribution of EGFR mutation by ARMS in NSCLC patients among the different characteristics including smoking status, gender, age, PS score, and tumor stage
up to 2 years
Proportion of treatment-naive patients with EGFR mutation detected by amplification refractory mutation system (ARMS) assay
Time Frame: up to 2 years
The investigators will describe the proportion of EGFR mutation on ctDNA detected by ARMS assay in treatment-naive patients with non-small cell lung cancer (NSCLC)
up to 2 years
Proportion of patients after first-line chemotherapy failure with EGFR mutation detected by amplification refractory mutation system (ARMS) assay
Time Frame: up to 2 years
The investigators will describe the proportion of EGFR mutation on ctDNA detected by ARMS assay in non-small cell lung cancer (NSCLC) patients after first-line chemotherapy failure
up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First People's Hospital of Hangzhou

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Actual)

July 1, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

December 3, 2015

First Submitted That Met QC Criteria

December 4, 2015

First Posted (Estimate)

December 7, 2015

Study Record Updates

Last Update Posted (Actual)

February 13, 2018

Last Update Submitted That Met QC Criteria

February 12, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20154701

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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