Patient-derived Organoids of Lung Cancer to Test Drug Response

Recruiting

• Conditions: Organoid; Lung Cancer

• Registration Number: NCT03979170
• Lead Sponsor: University Hospital, Geneva

Brief Summary

This is a single center, single arm, open and exploratory clinical study, with 50 cases planned for a period of 3 years. The purpose of this study is to evaluate the consistency and accuracy of a Patient-Derived Organoid (PDO) Model of lung cancer to predict the clinical efficacy of anti-cancer drugs, in order to predict the best chemotherapy regimen for each given patient.

Detailed Description

The aim of the project is to use a combination of patient-derived organoid models:

* To amplify tumour tissue to obtain enough material for genomic and histological analysis

* to characterize the lung cancer sub-type

* To predict treatment (non)response.

The following points will be addressed:

1. First, the investigators plan to establish and characterize formation of organoids from biopsies of patients with lung cancer: in spheroids, in the 3D cellular model OncoCilAirTM (OncoTheis), and on the chick chorioallantoic membrane (CAM). Patient-derived organoids from tumoural tissue (PDO) will be characterized and compared to the original tumour.

2. Second, the investigators will test the chemoresponse (chemosensitivity and chemoresistance) of organoids to anti-cancer treatment.

Study Timeline

• Study Start: 2019-04-01
• Study First Submitted: 2019-04-15
• Study First Submitted QC: 2019-06-06
• Study First Posted: 2019-06-07
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-31
• Last Update Posted: 2024-06-03
• Primary Completion: 2026-12-30
• Study Completion: 2029-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Histologically proven lung cancer
• Age ≥ 18
• Written informed and signed consent
• Accessible to biopsy and/or surgery sample of metastasis and/or primitive tumour

Exclusion Criteria

• Less than 18 years of age
• Not able to give informed consent (language, intellectual capacities, etc.)
• Not accessible to biopsy and/or surgery sample
• Not enough lung tissue for a histological analysis or the remaining lung tissue is not enough to perform a routine pathological analysis.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patient-derived organoid validation	5 years	Proportion of patient-derived organoids that are histologically and genetically identical to the source tumour
Patient-derived organoid establishment	3 years	Successful generation of lung cancer organoids (growth of lung tumoral cells). The rate of successful generation of lung cancer organoids could vary with the age of the patient, the histological and molecular subtype of lung cancer

Secondary Outcome Measures

Name	Time	Method
Drug sensitivity	2019 - 2023	Drug sensitivity of patient-derived tumour organoids (drug screening and chemotherapy resistance test) Secondary drug effects on patient-derived normal lung organoids
Prediction of the response to treatment by the patient-derived organoids	2020 - 2025	The drug sensitivity was tested on patient-derived tumour organoids, which is compared with clinical response of the chemo- or targeted therapy treatment.

Trial Locations

Locations (1)

Geneva University Hospitals; 🇨🇭 Geneva, Switzerland