Generation of Lung Tumor Organoids From Patients Undergoing Diagnostic Bronchoscopy

Not Applicable

Recruiting

• Conditions: Generation of Lung Cancer Organoids
• Interventions: Procedure: Biopsies performed via bronchoscopy

• Registration Number: NCT06239584
• Lead Sponsor: Regina Elena Cancer Institute

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.

Study Timeline

• Study Start: 2022-10-19
• Status Verified: 2024-01
• Study First Submitted: 2024-01-12
• Study First Submitted QC: 2024-01-25
• Last Update Submitted: 2024-01-25
• Primary Completion: 2024-02-02
• Study Completion: 2024-02-02
• Study First Posted: 2024-02-02
• Last Update Posted: 2024-02-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients undergoing diagnostic bronchoscopies for suspected lung cancer	Biopsies performed via bronchoscopy	Preparation of organoids starting from lung tumor tissue collected during biopsies performed via diagnostic bronchoscopy according to standard clinical practice

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (1)

"Regina Elena" National Cancer Institute; 🇮🇹 Rome, Italy