Clinical trial NCT05092009: Lung Cancer Organoids and Patient Derived Tumor Xenografts
Official title: Lung Cancer Organoids and Patient Derived Tumor Xenografts
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lung Cancer
Lead sponsor: Maastricht Radiation Oncology
Sponsor class: OTHER
First posted: 2021-10-25
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with 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.

Eligibility 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

Primary outcomes:
measure: Lung cancer organoids
timeFrame: 1 year
measure: Lung cancer organoids
timeFrame: 1 year
measure: Lung cancer organoids
timeFrame: 1 year
Secondary outcomes:
measure: Oncogenetic drivers
timeFrame: 1 year
measure: Tumor heterogeneity
timeFrame: 1 year
measure: Molecular biology
timeFrame: 1 year
measure: Treatment response
timeFrame: 1 year
measure: Xenografts
timeFrame: 1 year
measure: Therapeutic approaches
timeFrame: 1 year
measure: Developing biomarkers
timeFrame: 1 year
measure: Analysing blood
timeFrame: 1 year
measure: Analysing blood
timeFrame: 1 year
measure: Analysing blood
timeFrame: 1 year
measure: Analysing blood
timeFrame: 1 year
measure: Analysing blood
timeFrame: 1 year
Other outcomes:
Locations:
city: Heerlen
country: Netherlands
facility: Zuyderland Medical Center
city: Maastricht
country: Netherlands
facility: Maastricht Radiation Oncology (Maastro)
city: Maastricht
country: Netherlands
facility: MUMC+
Study officials:
References: