Patient-derived Organoids of Lung Cancer to Test Drug Response

NCT03979170 | Recruiting

• 1 other identifier: 2018-02395
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer; Organoid

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Drug sensitivity

  2019 - 2023

• Prediction of the response to treatment by the patient-derived organoids

  2020 - 2025

Interventions

Lung tumor resection PROCEDURE

lung tumor resection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Histologically proven lung cancer
• Age ≥ 18
• Written informed and signed consent
• Accessible to biopsy and/or surgery sample of metastasis and/or primitive tumour

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Geneva: lead

Study Sites (1)

Geneva University Hospitals

Geneva, 1205, Switzerland

RECRUITING

Related 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.

  PMID: 38067281 BACKGROUND

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.

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Veronique SERRE-BEINIER, PhD

CONTACT

(0)223795107; veronique.serre-beinier@hcuge.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 15, 2019
• First Posted: June 7, 2019
• Study Start: April 1, 2019
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2029
• Last Updated: June 3, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)