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OpenTrials
Completed

NCT Number: NCT03562819

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Reserch Site, Punjab, Chandigarh, India

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients who provide written informed consent
  • Patients aged 18 years and older
  • Newly diagnosed patients with Metastatic (stage IV) NSCLC.
  • 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.
  • Patient should be naïve for any systemic treatment (i.e. no chemotherapy or EGFR-TKI)

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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).

Acronym: CONCORDANCE

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jun 20, 2018
Registry last updated
Jun 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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