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The goal of this observational study is to evaluate the feasibility of a single cell mutation research method in a panel of known oncogenes, using the Tapestri method. Tissue samples will be obtained after surgical treatment in patients with I-II-III stage NSCLC.
NSCLC is a particularly heterogeneous disease with different genetic alterations in oncogenes 'drivers', responsible for the development and progression of the disease. In most cases all these anomalies represent clonal mutations in all neoplastic cells. However, several sub-clonal genetic alterations were identified in some multi-regional sequencing studies, demonstrating an intra-tumor heterogeneity. Tracing the clonal architecture of the disease and also the temporal order of the various mutations appearance, would bring two benefits:
Given the limited number of patients that can be included in the study (10 patients), no statistical analyzes will be performed. Results will be presented thorugh narrative reports for each patients.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tapestry technology | Other | The study involves the immediate freezing and preservation in liquid nitrogen of a tumor histological sample from surgical resection, obtained from the operating room, within one hour of removal. Surgery is part of the normal clinical practice of patients with lung cancer. |
| Measure | Description | Time Frame |
|---|---|---|
| Tapestri success rate | Evaluation of the feasibility of a single cell mutation search method in a panel of known oncogenes, using Tapestri technology, in tumor tissue obtained from stage I-II-III NSCLC patients after surgical treatment planned in clinical practice. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects older than 18 years old, male and female, with histological diagnosis of NSCLC technically operable following multisciplinary discussion.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione IRCCS San Gerardo dei Tintori | Recruiting | Monza | MB | 20900 | Italy |
Upon request
After publication
Upon request
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Tissue samples obtained from surgical treatment