Radiation side-effects can be predicted by irradiating patient specific lung epithelial organoids in vitro.
ID
Bron
Verkorte titel
Aandoening
Stage III NSCLC
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
A significant difference in the number of yH2AX foci (double strand DNA damage) per cell induced by in vitro radiation between
patient-specific normal epithelial cells from patients with grade 2 or higher pneumonitis or fibrosis following chemoradiation or proton
therapy based on CTCAE scoring system and patients with grade 1 or lower pneumonitis or fibrosis.
Achtergrond van het onderzoek
Background of the study:
Standard of care for patients with stage III non-small cell lung cancer (NSCLC) is chemotherapy combined with concurrent or
sequential radiotherapy. Radiation-induced lung injury (RILI) of normal lung tissue is one of the main dose-limiting factors during
radiation treatment. Therefore, it is important to identify which patients are at risk for RILI to be able to create a personalized
radiation treatment and prevent reduction in quality of life (QOL) in cancer survivors. So far, no reliable biomarkers have been found
that can be used for this identification. This study aims to use patient-derived airway epithelial organoids to search for individual
predictors for RILI.
Objective of the study:
To demonstrate the validity of using patient-derived lung epithelial organoids, as a model of normal lung tissue, we aim to assess
lung epithelial cell responses to ionizing radiation exposure and relate these to clinical outcome. In addition, clinical outcome
parameters will be combined to create a better understanding of RILI.
Study design: This study is a prospective cross-sectional study.
Doel van het onderzoek
Radiation side-effects can be predicted by irradiating patient specific lung epithelial organoids in vitro.
Onderzoeksopzet
3, 6, and 12 months
Onderzoeksproduct en/of interventie
Bronchoalveolar lavage
Algemeen / deelnemers
Wetenschappers
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
• Age > 18-85 years;
• Clinical suspicion of lung tumor with mediastinal lymph node involvement based on enlarged lymph nodes on CT
thorax or FDG uptake on PET-CT conform ESMO guidelines;
• Planned bronchoscopy with endobronchial ultrasound (EBUS) with sedation (Propofol or benzodiazepine) for
standard diagnostic work -up;
• Clinical performance adequate for undergoing EBUS (according to pulmonary physician ordering the diagnostic
procedure).
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
• Clinical performance too low to undergo EBUS according to pulmonary physician ordering the diagnostic
procedure;
• Suspicion of metastasis or stage IV disease on PET-CT or CT-thorax;
• Inadequate understanding of the Dutch language in speech and writing.
• Clinical performance too low to receive chemoradiotherapy or proton therapy;
• Significant co-morbidities such as end stage renal disease, severe cardiovascular disease, severe psychiatric
disease, end stage COPD, or other comorbidity with limited expected survival (<1 year) or WHO performance
status >3;
• Known pre-existent diagnosis of lung fibrosis or newly diagnosed lung fibrosis before start of the study;
• Previous thoracic radiation-treatment.
Opzet
Deelname
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL9142 |
| Ander register | METC LDD : P20.070 |