Patient-derived Organoids of Lung Cancer to Test Drug Response

Lung Cancer Clinical Trial

Official title:

Patient-derived Organoids of Lung Cancer to Test Drug Response

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03979170
• Other study ID #: 2018-02395
• Status: Recruiting
• Start date: April 1, 2019
• Est. completion date: December 30, 2029

Study information

• Verified date: May 2024
• Source: University Hospital, Geneva
• Contact: Veronique SERRE-BEINIER, PhD
• Phone: (0)223795107
• Email: veronique.serre-beinier[@]hcuge.ch
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 30, 2029
• Est. primary completion date: December 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms
• Organoid

Intervention

Procedure:
• Lung tumor resection
lung tumor resection

Locations

Country	Name	City	State
Switzerland	Geneva University Hospitals	Geneva

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Geneva

Country where clinical trial is conducted

Switzerland, 

References & Publications (1)

Mueggler A, Pilotto E, Perriraz-Mayer N, Jiang S, Addeo A, Bedat B, Karenovics W, Triponez F, Serre-Beinier V. An Optimized Method to Culture Human Primary Lung Tumor Cell Spheroids. Cancers (Basel). 2023 Nov 25;15(23):5576. doi: 10.3390/cancers15235576. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Patient-derived organoid validation	Proportion of patient-derived organoids that are histologically and genetically identical to the source tumour	5 years
Secondary	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
Secondary	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

External Links

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