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Lung Cancer Organoids and Patient Derived Tumor Xenografts (Lung organoids)

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ClinicalTrials.gov Identifier: NCT05092009
Recruitment Status : Recruiting
First Posted : October 25, 2021
Last Update Posted : August 26, 2022
Sponsor:
Information provided by (Responsible Party):
Maastricht Radiation Oncology

Brief Summary:
Extra tissue will be taken from patient during a procedure in standard of care. Also, through an existing line, 10ml of extra blood will be drawn. From this material the investigator will try to establish matched normal and primary human lung cancer organoids.

Condition or disease Intervention/treatment
Lung Cancer Other: Tissue and blood

Detailed Description:

Lung (tumor) material obtained from biopsies or surgical resection material that is not needed by the pathologist for diagnosis (i.e. to stage the patient or to perform molecular diagnosis) will be collected and used for the generation of matched normal and lung cancer organoids and/or PDX.

Biopsy material: Patients with (suspected) lung cancer will undergo a bronchoscopy or endobronchial ultrasound guided transbronchial needle aspiration (EBUS/EUS-TBNA) bronchoscopy for the collection of a lung / lymph node biopsy. Biopsies are collected according to standard of care procedures for i.e. the initial diagnosis and staging of lung cancer, and molecular profiling of recurrent tumors. During the standard of care biopsy procedure, an extra biopsy (lung and/or lymph node) will be collected and used for the generation of lung (cancer) organoids:

  • Bronchoscopy: biopsy-derived lung (tumor) tissue from endobronchial tumors
  • EBUS/EUS-TBNA bronchoscopy: cytology-derived lung (tumor) cells from mediastinal lymph nodes

A 10 ml blood sample will only be collected at the moment blood must be drawn according to standard of care procedures or when the patient has received an intravenous drip. The patient therefore does not require to undergo additional procedures.

Resection material: Patients who are selected to undergo surgical removal of a primary lung cancer will be included. The (tumor) material that will be used to make organoids and PDX will be derived from remaining healthy and tumor tissue that is not needed for the pathologist to make a diagnosis, to stage the patient or to perform a molecular diagnosis. The patient therefore does not require to undergo additional treatments or procedures. A 10 ml blood sample will be collected at the moment blood must be drawn pre-operatively according to standard of care procedures or from the intravenous drip the patient will receive before start surgery. The patient therefore does not require to undergo additional procedures.

Collection of clinical data: Clinical data will be collected from existing standard of care data:

  • Histology
  • Date diagnosis lung cancer
  • TNM classification (eight edition)
  • If performed, molecular analysis data such as Epidermal Growth Factor Receptor (EGFR) mutation, Anaplastic Lymphoma Kinase (ALK) translocation, Kirsten Rat Sarcoma (KRAS) viral oncogene homolog mutation etc. (Type of test, results)
  • PD-L1 status if available. If available, type of test and PD-L1%
  • Type, dose, and date of treatment the patient received before and/or after the collection tumor biopsy (chemotherapy, radiotherapy, tyrosine kinase inhibitors, immunotherapy). If applicable, also the date and dose of all cycles.

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Study Type : Observational
Estimated Enrollment : 600 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Lung Cancer Organoids and Patient Derived Tumor Xenografts
Estimated Study Start Date : September 1, 2022
Estimated Primary Completion Date : April 1, 2023
Estimated Study Completion Date : April 1, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Group/Cohort Intervention/treatment
All patiens
There is only one arm in this trial
Other: Tissue and blood
Tissue and blood will be derived from patient during a standard of care procedure




Primary Outcome Measures :
  1. Lung cancer organoids [ Time Frame: 1 year ]

    Establishing matched normal and primary human lung cancer organoids from patient-derived (tumor) tissue material by establishing long term culturing and bio-banking conditions for matched normal and primary lung cancer organoids from patient-derived lung (tumor) material. From these, we will In the established organoids we will:

    • the rate of proliferation and cell death (turnover) will be calculated


  2. Lung cancer organoids [ Time Frame: 1 year ]

    Establishing matched normal and primary human lung cancer organoids from patient-derived (tumor) tissue material by establishing long term culturing and bio-banking conditions for matched normal and primary lung cancer organoids from patient-derived lung (tumor) material. From these, we will In the established organoids we will:

    • the size distribution of the organoids


  3. Lung cancer organoids [ Time Frame: 1 year ]

    Establishing matched normal and primary human lung cancer organoids from patient-derived (tumor) tissue material by establishing long term culturing and bio-banking conditions for matched normal and primary lung cancer organoids from patient-derived lung (tumor) material. From these, we will In the established organoids we will:

    • determine the frequency of primary, secondary and tertiary organoid formation



Secondary Outcome Measures :
  1. Oncogenetic drivers [ Time Frame: 1 year ]
    To define oncogenic drivers in lung cancer organoids

  2. Tumor heterogeneity [ Time Frame: 1 year ]
    To investigate the stability of (epi-) genetic and phenotypic tumor heterogeneity of cultured organoids compared to a primary/secondary biopsy

  3. Molecular biology [ Time Frame: 1 year ]
    To predict sensitivity and to get insight in the molecular biology of the response to immunotherapy, radiotherapy, cytotoxic and targeted agents

  4. Treatment response [ Time Frame: 1 year ]
    To compare treatment response in normal lung organoids and lung cancer organoids

  5. Xenografts [ Time Frame: 1 year ]
    To establish and characterize patient-derived tumor xenografts

  6. Therapeutic approaches [ Time Frame: 1 year ]
    To test novel therapeutic approaches in lung cancer organoids and clinically relevant PDX models, including radiotherapy combined with hypoxia activated prodrugs and immunotherapies

  7. Developing biomarkers [ Time Frame: 1 year ]
    To develop biomarker(s) of tumor response to be able to select patients who will benefit from novel treatment strategies.

  8. Analysing blood [ Time Frame: 1 year ]
    To analyze (ct)DNA in organoid-derived culture supernatants and corresponding patient-derived blood samples

  9. Analysing blood [ Time Frame: 1 year ]
    To analyze metabolites in organoid-derived culture supernatants and corresponding patient-derived blood samples

  10. Analysing blood [ Time Frame: 1 year ]
    To analyze RNA in organoid-derived culture supernatants and corresponding patient-derived blood samples

  11. Analysing blood [ Time Frame: 1 year ]
    To analyze proteins in organoid-derived culture supernatants and corresponding patient-derived blood samples

  12. Analysing blood [ Time Frame: 1 year ]
    To analyze microvesicles secreted by lung cancer cells in organoid-derived culture supernatants and corresponding patient-derived blood samples


Biospecimen Retention:   Samples With DNA
Blood and tumour tissue


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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
Patients with lung cancer
Criteria

Inclusion Criteria:

  • All patients selected to undergo primary surgical resection of a primary lung cancer. All types of resection are eligible, e.g. wedge resection, segmental resection, lobectomy, pneumonectomy.
  • All patients with (suspected) lung cancer that will undergo a bronchoscopy or endobronchial ultrasound guided transbronchial needle aspiration (EBUS/EUS-TBNA) bronchoscopy.

Exclusion Criteria:

There are no exclusion criteria


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): NCT05092009


Contacts
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Contact: Chantal Overhof, BEc. +31 88 44 55 863 chantal.overhof@maastro.nl
Contact: Ann Claessens +31 88 44 55 863 ann.claessens@maastro.nl

Locations
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Netherlands
Zuyderland Medical Center Recruiting
Heerlen, Netherlands, 6419 PC
Contact: Juliette Degens, MD, PhD    +31 884597810    juliette.degens@zuyderland.nl   
Principal Investigator: Juliette Degens, MD, PhD         
Maastricht Radiation Oncology (Maastro) Not yet recruiting
Maastricht, Netherlands, 6229 ET
Contact: Chantal Overhof, BEc.    +31 884455863    chantal.overhof@maastro.nl   
Contact: Ann Claessens    +31 884455863    ann.claessens@maastro.nl   
Principal Investigator: Dirk De Ruysscher, MD, PhD         
MUMC+ Recruiting
Maastricht, Netherlands, 6229 HX
Contact: Roy Sprooten, MD    +31 43 3871318    r.sprooten@mumc.nl   
Principal Investigator: Roy Sprooten, MD         
Sponsors and Collaborators
Maastricht Radiation Oncology
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Responsible Party: Maastricht Radiation Oncology
ClinicalTrials.gov Identifier: NCT05092009    
Other Study ID Numbers: Lung Organoids
First Posted: October 25, 2021    Key Record Dates
Last Update Posted: August 26, 2022
Last Verified: August 2022
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