Study to Evaluate Concordance of Detecting EGFR (Epidermal Growth Factor Receptor) Mutation by Circulating Tumour Free DNA Versus Tissues Biopsy in NSCLC (Non-small Cell Lung Cancer). (CONCORDANCE)

June 4, 2020 updated by: AstraZeneca

An Observational, Multicentre, Prospective Study to Evaluate Concordance of Detecting EGFR (Epidermal Growth Factor Receptor) Mutation by Circulating Tumour Free DNA Versus Tissues Biopsy in NSCLC (Non-small Cell Lung Cancer).

This is a multicentre, prospective, study of EGFR )Epidermal Growth Factor Receptor) mutation status in advanced NSCLC (Non-small cell lung cancer)patients (locally advanced and/or metastatic disease) with adenocarcinoma histology proposed to be conducted at 15 sites from different geographical regions across India. The study targets to enrol 268 patients over a period of 6 months.

Study Overview

Status

Completed

Conditions

Detailed Description

This is a multicentre, prospective, study of EGFR mutation status in advanced NSCLC patients (locally advanced and/or metastatic disease) with adenocarcinoma histology proposed to be conducted at 15 sites from different geographical regions across India. The study targets to enrol 268 patients over a period of 6 months. The study will enroll patients with histologically confirmed, systemic treatment naïve adenocarcinoma metastatic cancer (stage IV). This will be a single visit study. No study medication will be prescribed or administered as a part of study procedure.

Study Type

Observational

Enrollment (Actual)

268

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

  • India
    • Chandigarh
      • Punjab, Chandigarh, India, 160055
        • Reserch site
    • Delhi
      • New Delhi, Delhi, India, 110029
        • Research Site
      • New Delhi, Delhi, India, 110085
        • Research Site
      • New Delhi, Delhi, India, 110063
        • Research Site
    • Karnataka
      • Bengaluru, Karnataka, India, 560027
        • Research Site
    • Kozhikode
      • Kerala, Kozhikode, India, 673601
        • Research Site
    • Maharashtra
      • Mumbai, Maharashtra, India, 400012
        • Research Site
      • Mumbai, Maharashtra, India, 400071
        • Research Site
    • Mumbai
      • Maharashtra, Mumbai, India, 400016
        • Research Site
    • Odisha
      • Bhubaneswar, Odisha, India, 751007
        • Research Site
    • Telanagana
      • Hyderabad, Telanagana, India, 500034
        • Research Site
    • West Bangal
      • Kolkata, West Bangal, India, 700160
        • Research Site
    • West Bengal
      • Kolkata, West Bengal, India, 700054
        • Research Site
      • Kolkata, West Bengal, India, 700063
        • Research Site

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

NSCLC (Non-small cell lung cancer)

Description

Inclusion Criteria:

  1. Patients who provide written informed consent
  2. Patients aged 18 years and older
  3. Newly diagnosed patients with Metastatic (stage IV) NSCLC.
  4. Histologically confirmed Adenocarcinoma NSCLC patient as per tissue biopsy and Tissue sample sent for EGFR mutation analysis OR result for EGFR mutation test is available from last 28 days from the date of enrolment.
  5. Patient should be naïve for any systemic treatment (i.e. no chemotherapy or EGFR-TKI)

Exclusion Criteria:

  1. Patient with any medical condition that, in the opinion of the investigator, would interfere with outcome of the study
  2. Patient participating in any other interventional clinical study/trial.

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

Cohorts and Interventions

Group / Cohort
NSCLC
Non-small cell lung cancer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determine the level of concordance between EGFR mutation status
Time Frame: 1 Day
by tissue and plasma based testing in terms of Overall Concordance, Sensitivity, specificity, Positive predictive value & negative predictive value.
1 Day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess the frequency of T790M mutation among study patients.
Time Frame: 1 Day
Frequency and percentage of TKI treatment naïve NSCLC patients with T790M mutation will be provided.
1 Day

Collaborators and Investigators

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

Sponsor

AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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 (Actual)

August 16, 2018

Primary Completion (Actual)

June 7, 2019

Study Completion (Actual)

June 7, 2019

Study Registration Dates

First Submitted

May 22, 2018

First Submitted That Met QC Criteria

June 8, 2018

First Posted (Actual)

June 20, 2018

Study Record Updates

Last Update Posted (Actual)

June 5, 2020

Last Update Submitted That Met QC Criteria

June 4, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D5161R00003

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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