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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NSCLC | Non-small cell lung cancer |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Assess the frequency of T790M mutation among study patients. | Frequency and percentage of TKI treatment naïve NSCLC patients with T790M mutation will be provided. | 1 Day |
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Inclusion Criteria:
Exclusion Criteria:
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NSCLC (Non-small cell lung cancer)
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Reserch Site | Punjab | Chandigarh | 160055 | India | ||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35343188 | Derived | 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. |
| Label | URL |
|---|---|
| Related Info | View source |
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| 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 |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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