Patient-derived Organoids of Lung Cancer to Test Drug Response
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|ClinicalTrials.gov Identifier: NCT03979170|
Recruitment Status : Recruiting
First Posted : June 7, 2019
Last Update Posted : June 7, 2019
|Condition or disease||Intervention/treatment|
|Lung Cancer Organoid||Procedure: Lung tumor resection|
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.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||50 participants|
|Target Follow-Up Duration:||1 Day|
|Official Title:||Patient-derived Organoids of Lung Cancer to Test Drug Response|
|Actual Study Start Date :||April 1, 2019|
|Estimated Primary Completion Date :||December 30, 2021|
|Estimated Study Completion Date :||December 30, 2024|
- Procedure: Lung tumor resection
lung tumor resection
- Patient-derived organoid establishment [ Time Frame: 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
- Patient-derived organoid validation [ Time Frame: 5 years ]Proportion of patient-derived organoids that are histologically and genetically identical to the source tumour
- Drug sensitivity [ Time Frame: 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 [ Time Frame: 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.
Biospecimen Retention: Samples With DNA
Biospecimen retention: blood; cells; tumour tissue for immunohistochemical analysis.
Tissue of lung cancer will be collected during surgery in a way that will not interfere with subsequent pathological analysis and staging. Under the premise of ensuring normal detection requirements, a certain volume of fresh tumour tissues will be subjected to ex vivo 3-D culture to establish patient-derived tumour organoid models. The lung patient-derived organoids will be characterized. The organs successfully cultured will be kept in liquid nitrogen for at least 10 years.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03979170
|Contact: Veronique SERRE-BEINIER, PhD||(0)223795107 ext +firstname.lastname@example.org|
|Geneva University Hospitals||Recruiting|
|Geneva, Switzerland, 1205|
|Contact: Veronique SERRE-BEINIER, PhD 223795107 ext 41 email@example.com|
|Principal Investigator: Frederic TRIPONEZ, MD|
|Principal Investigator: Wolfram KARENOVICS, MD|