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Lung Cancer Organoids and Patient Derived Tumor Xenografts

Lung Cancer Organoids and Patient Derived Tumor Xenografts

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05092009
Acronym
IPON-3
Enrollment
600
Registered
2021-10-25
Start date
2022-10-05
Completion date
2028-04-01
Last updated
2026-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer

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.

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.

Interventions

OTHERTissue and blood

Tissue and blood will be derived from patient during a standard of care procedure

Sponsors

Maastricht Radiation Oncology
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Lung cancer organoids1 yearEstablishing 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

Secondary

MeasureTime frameDescription
Oncogenetic drivers1 yearTo define oncogenic drivers in lung cancer organoids
Tumor heterogeneity1 yearTo investigate the stability of (epi-) genetic and phenotypic tumor heterogeneity of cultured organoids compared to a primary/secondary biopsy
Molecular biology1 yearTo predict sensitivity and to get insight in the molecular biology of the response to immunotherapy, radiotherapy, cytotoxic and targeted agents
Treatment response1 yearTo compare treatment response in normal lung organoids and lung cancer organoids
Xenografts1 yearTo establish and characterize patient-derived tumor xenografts
Therapeutic approaches1 yearTo test novel therapeutic approaches in lung cancer organoids and clinically relevant PDX models, including radiotherapy combined with hypoxia activated prodrugs and immunotherapies
Developing biomarkers1 yearTo develop biomarker(s) of tumor response to be able to select patients who will benefit from novel treatment strategies.
Analysing blood1 yearTo analyze (ct)DNA in organoid-derived culture supernatants and corresponding patient-derived blood samples

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 14, 2026