An observational, multicentre, prospective study to see concordance of detecting EGFR mutation by circulating tumour free DNA versus tissues biopsy in Non small cell lung cancer
Not Applicable
Completed
- Conditions
- Health Condition 1: C342- Malignant neoplasm of middle lobe,bronchus or lungHealth Condition 2: null- Non-small cell lung cancer
- Registration Number
- CTRI/2018/08/015290
- Lead Sponsor
- AstraZeneca Pharma India Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 245
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 patients as per tissue biopsy and the sample sent for EGFR mutation analysis.
5. Patient should be naïve for any systemic treatment (i.e. no chemotherapy or EGFR-TKI)
6. Provision of a routine blood (plasma) sample
The prescription of any medicinal product is clearly separated from the decision to include the subject in the study.
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 & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Determine the level of concordance between EGFR mutation status obtained by tissue and blood (plasma) based testing in terms of Overall Concordance, Sensitivity specificity Positive predictive value and negative predictive valueTimepoint: one day
- Secondary Outcome Measures
Name Time Method 1. Determine the frequency of mutations on Exon 19,20 & 21 of EGFR gene (including mutation subtypes: exon 19 deletions and the L858R) among study patients as assessed by the plasma samples <br/ ><br>2. Assess the frequency of T790M mutation among study patientsTimepoint: one day