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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
Sponsor:
Information provided by (Responsible Party):
Frederic TRIPONEZ, University Hospital, Geneva

Brief 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.

Condition or disease Intervention/treatment
Lung Cancer Organoid 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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer


Intervention Details:
  • Procedure: Lung tumor resection
    lung tumor resection


Primary Outcome Measures :
  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 Outcome Measures :
  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.


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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
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.

Information from the National Library of Medicine

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


Contacts
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Contact: Veronique SERRE-BEINIER, PhD (0)223795107 ext +41 veronique.serre-beinier@hcuge.ch

Locations
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Switzerland
Geneva University Hospitals Recruiting
Geneva, Switzerland, 1205
Contact: Veronique SERRE-BEINIER, PhD    223795107 ext 41    veronique.serre-beinier@hcuge.ch   
Principal Investigator: Frederic TRIPONEZ, MD         
Principal Investigator: Wolfram KARENOVICS, MD         
Sponsors and Collaborators
University Hospital, Geneva

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Responsible Party: Frederic TRIPONEZ, Professor, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT03979170     History of Changes
Other Study ID Numbers: 2018-02395
First Posted: June 7, 2019    Key Record Dates
Last Update Posted: June 7, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases