Patient-derived Organoids of Lung Cancer to Test Drug Response

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.

Study Overview

• Status: Recruiting
• Conditions: Lung Cancer; Organoid
• Intervention / Treatment: Procedure: Lung tumor resection

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 Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Veronique SERRE-BEINIER, PhD; Phone Number: +41 (0)223795107; Email: veronique.serre-beinier@hcuge.ch

Study Locations

• Switzerland
  • Geneva, Switzerland, 1205
    • Recruiting
    • Geneva University Hospitals
    • Contact: Veronique SERRE-BEINIER, PhD; Phone Number: 41 223795107; Email: veronique.serre-beinier@hcuge.ch
    • Principal Investigator: Frederic TRIPONEZ, MD
    • Principal Investigator: Wolfram KARENOVICS, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All patients (estimated 50 patients) with histologically proven lung cancer undergoing surgery related to this cancer at the University Hospitals of Geneva.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Geneva

Publications and helpful links

General Publications

• 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.

Helpful Links

• publication

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2019
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2029

Study Registration Dates

• First Submitted: April 15, 2019
• First Submitted That Met QC Criteria: June 6, 2019
• First Posted (Actual): June 7, 2019

Study Record Updates

• Last Update Posted (Actual): June 3, 2024
• Last Update Submitted That Met QC Criteria: May 31, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: 2018-02395

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No