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Prediciting Radiation-Induced lung injury through patient-specific lung epithelial ORganoids

Prediciting Radiation-Induced lung injury through patient-specific lung epithelial ORganoids

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON26284
Enrollment
65
Registered
2020-12-24
Start date
2021-01-10
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Stage III NSCLC

Interventions

Bronchoalveolar lavage

Sponsors

None listed

Eligibility

Inclusion criteria

Inclusion criteria: • 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).

Exclusion criteria

Exclusion criteria: • 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 (3; • Known pre-existent diagnosis of lung fibrosis or newly diagnosed lung fibrosis before start of the study; • Previous thoracic radiation-treatment.

Design outcomes

Primary

MeasureTime frame
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.

Secondary

MeasureTime frame
Other in vitro measurements of e.g. EMT, changes in lung function, CT-densitometry, lung function and diffusion capacity

Contacts

Public ContactMerian Kuipers

Leiden University Medical Centre

m.e.kuipers1@lumc.nl071-5299481

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)