Clinical trial · Observational
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).
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| NSCLC (Non-small Cell Lung Cancer) | Lung Non-Small Cell Carcinoma | ALIAS | 0.85 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- NSCLC
- description
- Non-small cell lung cancer
Primary outcomes (1)
- measure
- Determine the level of concordance between EGFR mutation status
- timeFrame
- 1 Day
- description
- by tissue and plasma based testing in terms of Overall Concordance, Sensitivity, specificity, Positive predictive value \& negative predictive value.
Secondary outcomes (1)
- measure
- Assess the frequency of T790M mutation among study patients.
- timeFrame
- 1 Day
- description
- Frequency and percentage of TKI treatment naïve NSCLC patients with T790M mutation will be provided.
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDPrabhash 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 35343188