Patient-derived Organoids of Lung Cancer to Test Drug Response

Study Overview
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Brief Summary
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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
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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: 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. Second, the investigators will test the chemoresponse (chemosensitivity and chemoresistance) of organoids to anti-cancer treatment.

Official Title
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Patient-derived Organoids of Lung Cancer to Test Drug Response

Conditions
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Lung Cancer, Organoid

Intervention / Treatment
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* Procedure: Lung tumor resection


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Lung tumor resection|lung tumor resection|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient-derived organoid establishment | 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 | 3 years | 
| Patient-derived organoid validation | Proportion of patient-derived organoids that are histologically and genetically identical to the source tumour | 5 years | 

Secondary Outcome Measures

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