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).

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

268 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-08-16

Study Completion Date

2019-06-07

Brief Summary

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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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Detailed Description

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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.

Conditions

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NSCLC (Non-small Cell Lung Cancer)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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NSCLC

Non-small cell lung cancer

No interventions assigned to this group

Eligibility Criteria

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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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No