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Trial Title:
Generation of Lung Tumor Organoids From Patients Undergoing Diagnostic Bronchoscopy
NCT ID:
NCT06239584
Condition:
Generation of Lung Cancer Organoids
Conditions: Official terms:
Lung Neoplasms
Conditions: Keywords:
Organoids.
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Biopsies performed via bronchoscopy
Description:
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
Arm group label:
Patients undergoing diagnostic bronchoscopies for suspected lung cancer
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
"Regina Elena" National Cancer Institute
Address:
City:
Rome
Zip:
00144
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Giovanni Blandino, Doctor
Phone:
06-5266.2911
Phone ext:
+39
Email:
giovanni.blandino@ifo.it
Start date:
October 19, 2022
Completion date:
February 2, 2024
Lead sponsor:
Agency:
Regina Elena Cancer Institute
Agency class:
Other
Collaborator:
Agency:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Agency class:
Other
Source:
Regina Elena Cancer Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06239584
