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| Name | Class |
|---|---|
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS | OTHER |
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Interventional (low intervention level), non-pharmacological, prospective, feasibility pilot study of the preparation of organoids starting from lung tumor tissue collected during biopsies performed via diagnostic bronchoscopy according to standard clinical practice.
Interventional, non-pharmacological, prospective, feasibility pilot study of the preparation of organoids starting from lung tumor tissue collected during biopsies performed via diagnostic bronchoscopy according to standard clinical practice. This protocol is classified as "interventional" (low intervention level) since that, if possible, an additional quantity of lung tumor tissue will be collected compared to that normally obtained as standard clinical practice, during bronchoscopy, al in order to increase the probability of successful generation of organoids. Involves the prospective recruitment of patients undergoing diagnostic bronchoscopies for suspected lung cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients undergoing diagnostic bronchoscopies for suspected lung cancer | Other | Preparation of organoids starting from lung tumor tissue collected during biopsies performed via diagnostic bronchoscopy according to standard clinical practice |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biopsies performed via bronchoscopy | Procedure | An additional amount of lung tumor tissue will be collected compared to that normally obtained as standard clinical practice, during bronchoscopy, al in order to increase the probability of successful generation of organoids |
| Measure | Description | Time Frame |
|---|---|---|
| Preparation of at least 10 tumor organoid cultures lung | Preparation of at least 10 tumor organoid cultures lung derived from patients undergoing diagnostic bronchoscopy. This study will allow define the success rate in the generation of organoids from diagnostic bronchoscopies. Performing a diagnostic bronchoscopy (scheduled as per clinical practice). | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Correspondence between the generated organoids and the tissue tumor of origin | Verify the correspondence between the generated organoids and the tissue tumor of origin. Expecting to carry out broad-spectrum molecular investigations, such as DNA mutational analysis via Whole Exome Sequencing (WES), and expression profiling gene through RNA-sequencing (RNAseq),through the use of the AllPrep DNA/RNA/miRNA Universal Kit (Quiagen) and of the tumors of origin taken through bronchoscopy diagnostics, as well as derived organoid cultures (PDO). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Giovanni Blandino, Doctor | Contact | 06-5266.2911 | +39 | giovanni.blandino@ifo.it |
| Federico cappuzzo, Doctor | Contact | 06.5266.5698 | +39 | federico.cappuzzo@ifo.it |
| Name | Affiliation | Role |
|---|---|---|
| Giovanni Blandino, Doctor | IRCCS "Regina Elena" National Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| "Regina Elena" National Cancer Institute | Recruiting | Rome | 00144 | Italy |
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| 12 months |