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Recruiting NCT03979170

Patient-derived Organoids of Lung Cancer to Test Drug Response

Observational Lung Cancer Organoid

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Lung tumor resection.
Who it may be relevant to
Registry conditions: Lung Cancer, Organoid. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Switzerland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Procedure Lung tumor resection
    lung tumor resection

Primary outcome measures

  • Patient-derived organoid establishment [Time frame: 3 years]
  • Patient-derived organoid validation [Time frame: 5 years]
Secondary outcome measures (2)
  • Drug sensitivity [Time frame: 2019 - 2023]
  • Prediction of the response to treatment by the patient-derived organoids [Time frame: 2020 - 2025]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Switzerland · 1 center
  • Geneva University Hospitals — Geneva

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. PMID 38067281

Identifiers

NCT: NCT03979170 · 2018-02395

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗