Generation of Lung Cancer Organoids
Conditions
Keywords
Organoids.
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREBiopsies performed via bronchoscopy
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
Sponsors
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Regina Elena Cancer Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* patients with suspected diagnosis of centrally located and accessible lung cancer endoscopically; * patients for whom it is indicated to undergo in-depth diagnostic testing through bronchoscopy for the purpose of determining the histotype of the lung neoplasm, according to clinical practice standard; * aged over 18; * patients who express informed consent to the study.
Exclusion criteria
* medical contraindication to taking biopsy samples; * medical contraindication to carrying out endoscopic investigations; * patients with suspected lung cancer not accessible endoscopically; * patients with lung neoformation already subjected to diagnostic sampling; * contraindications to taking an additional quantity of tissue.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Preparation of at least 10 tumor organoid cultures lung | 12 months | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Correspondence between the generated organoids and the tissue tumor of origin | 12 months | 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). |
Countries
Italy
Contacts
Primary ContactGiovanni Blandino, Doctor
Backup ContactFederico cappuzzo, Doctor
Outcome results
None listed