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
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).
1 other identifier
observational
268
1 country
14
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2018
Shorter than P25 for all trials
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 22, 2018
CompletedFirst Posted
Study publicly available on registry
June 20, 2018
CompletedStudy Start
First participant enrolled
August 16, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 7, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 7, 2019
CompletedJune 5, 2020
June 1, 2020
10 months
May 22, 2018
June 4, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Determine the level of concordance between EGFR mutation status
by tissue and plasma based testing in terms of Overall Concordance, Sensitivity, specificity, Positive predictive value \& negative predictive value.
1 Day
Secondary Outcomes (1)
Assess the frequency of T790M mutation among study patients.
1 Day
Study Arms (1)
NSCLC
Non-small cell lung cancer
Eligibility Criteria
NSCLC (Non-small cell lung cancer)
You may qualify if:
- 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)
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (14)
Reserch Site
Punjab, Chandigarh, 160055, India
Research Site
Bengaluru, Karnataka, 560027, India
Research Site
Kerala, Kozhikode, 673601, India
Research Site
Mumbai, Maharashtra, 400012, India
Research Site
Mumbai, Maharashtra, 400071, India
Research Site
Maharashtra, Mumbai, 400016, India
Research Site
New Delhi, National Capital Territory of Delhi, 110029, India
Research Site
New Delhi, National Capital Territory of Delhi, 110063, India
Research Site
New Delhi, National Capital Territory of Delhi, 110085, India
Research Site
Bhubaneswar, Odisha, 751007, India
Research Site
Hyderabad, Telanagana, 500034, India
Research Site
Kolkata, West Bangal, 700160, India
Research Site
Kolkata, West Bengal, 700054, India
Research Site
Kolkata, West Bengal, 700063, India
Related Publications (1)
Prabhash K, Biswas B, Khurana S, Batra U, Biswas G, Advani SH, Mohapatra PN, Rajappa S, Sharma A, Patil S, Dattatreya PS, Roy R, Almel S, Goyal G, Warrier N. CONCORDANCE: A real-world evidence study to evaluate the concordance of detecting epidermal growth factor receptor (EGFR) mutation by circulating tumor DNA* versus tissue biopsy in patients with metastatic non-small cell lung cancer. Indian J Cancer. 2022 Mar;59(Supplement):S11-S18. doi: 10.4103/ijc.ijc_438_21.
PMID: 35343188DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 22, 2018
First Posted
June 20, 2018
Study Start
August 16, 2018
Primary Completion
June 7, 2019
Study Completion
June 7, 2019
Last Updated
June 5, 2020
Record last verified: 2020-06