Generation of Lung Tumor Organoids From Patients Undergoing Diagnostic Bronchoscopy

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.

Study Overview

• Status: Recruiting
• Conditions: Generation of Lung Cancer Organoids
• Intervention / Treatment: Procedure: Biopsies performed via bronchoscopy

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 Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Giovanni Blandino, Doctor; Phone Number: +39 06-5266.2911; Email: giovanni.blandino@ifo.it
• Study Contact Backup: Name: Federico cappuzzo, Doctor; Phone Number: +39 06.5266.5698; Email: federico.cappuzzo@ifo.it

Study Locations

• Italy
  • Rome, Italy, 00144
    • Recruiting
    • "Regina Elena" National Cancer Institute
    • Contact: Giovanni Blandino, Doctor; Phone Number: +39 06-5266.2911; Email: giovanni.blandino@ifo.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Patients undergoing diagnostic bronchoscopies for suspected lung cancer; Preparation of organoids starting from lung tumor tissue collected during biopsies performed via diagnostic bronchoscopy according to standard clinical practice	Procedure: Biopsies 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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).	12 months

Collaborators and Investigators

• Sponsor: Regina Elena Cancer Institute
• Collaborators: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Investigators: Principal Investigator: Giovanni Blandino, Doctor, IRCCS "Regina Elena" National Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): October 19, 2022
• Primary Completion (Estimated): February 2, 2024
• Study Completion (Estimated): February 2, 2024

Study Registration Dates

• First Submitted: January 12, 2024
• First Submitted That Met QC Criteria: January 25, 2024
• First Posted (Actual): February 2, 2024

Study Record Updates

• Last Update Posted (Actual): February 2, 2024
• Last Update Submitted That Met QC Criteria: January 25, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Organoids.
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: RS1766/22

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No