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NCT Number: NCT03979170

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.

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Key information

Conditions

Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Organoid Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Geneva University Hospitals

Geneva, 1205, Switzerland

Location status: Recruiting

Location contact

Frederic TRIPONEZ, MD

PRINCIPAL_INVESTIGATOR

Veronique SERRE-BEINIER, PhD

CONTACT

[email protected]

223795107 ext. 41

Wolfram KARENOVICS, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lung Tumor Resection

Procedure

lung tumor resection

Primary outcomes

  1. 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

  2. Patient-derived organoid validation

    Time frame: 5 years

    Proportion of patient-derived organoids that are histologically and genetically identical to the source tumour

Secondary outcomes

  1. 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

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Veronique SERRE-BEINIER, PhD

CONTACT

[email protected]

(0)223795107 ext. +41

Sponsors and collaborators

Lead sponsor

University Hospital, Geneva

Other

Registry information

Important dates

Study start
2019
Primary completion
2026
Study completion
2029
First posted
Jun 7, 2019
Registry last updated
Jun 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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