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).

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).

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03562819

Acronym

CONCORDANCE

Enrollment

268

Registered

2018-06-20

Start date

2018-08-16

Completion date

2019-06-07

Last updated

2020-06-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

NSCLC (Non-small Cell Lung Cancer)

Keywords

Epidermal Growth Factor Receptor

Brief summary

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.

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

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

Countries

India

Outcome results