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

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON52503

Enrollment

Registered

2020-12-08

Start date

2021-02-16

Completion date

Unknown

Last updated

2024-04-15

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

Conditions

Pulmonale fibrose en pneumontis na radiotherapie Radiation damage Radiation induced lung damage Radiation Induced Lung Injury

Interventions

None listed

Eligibility

Age

18 Years to 64 Years

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

Measure	Time frame
A significant difference in the number of H2AX foci (double strand DNA damage) per cell induced by in vitro radiation between patient-specific normal epithelial cells from patients with grade 2 pneumonitis or fibrosis following chemoradiation or proton therapy based on CTCAE scoring system and patients with grade * 1 pneumonitis or fibrosis.	—

Secondary

Measure	Time frame
In vitro: * Measurement of in vitro-induced changes in EMT (e.g. TGF-beta, alpha-SM-actin, SLUG, vimentin), -oxidative stress (e.g. HMOX1), or -inflammation (e.g. IL-6) by ionizing radiation in normal lung epithelial cell cultures derived from bronchoalveolar lavage fluid. Changes in the following clinical parameters following radiation: * Performance, symptoms and QOL as measured by questionnaires; * Lung function (VC, FVC, FEV1) and diffusion capacity (DLCOc, KCO); * Respiratory resistance (Rrs) and reactance (Xrs) as measured by forced oscillation technique; * Lung structure as measured by CTCAE grading on CT thorax; * Lung density measured by quantitative densitometry using CT-thorax. - The *-H2AX decay ratio in peripheral lymphocytes by measuring the difference in foci at 30 min and 24 hours after 1Gy radiation of peripheral lymphocytes.	—

Measure

Time frame

In vitro: * Measurement of in vitro-induced changes in EMT (e.g. TGF-beta, alpha-SM-actin, SLUG, vimentin), -oxidative stress (e.g. HMOX1), or -inflammation (e.g. IL-6) by ionizing radiation in normal lung epithelial cell cultures derived from bronchoalveolar lavage fluid. Changes in the following clinical parameters following radiation: * Performance, symptoms and QOL as measured by questionnaires; * Lung function (VC, FVC, FEV1) and diffusion capacity (DLCOc, KCO); * Respiratory resistance (Rrs) and reactance (Xrs) as measured by forced oscillation technique; * Lung structure as measured by CTCAE grading on CT thorax; * Lung density measured by quantitative densitometry using CT-thorax. - The *-H2AX decay ratio in peripheral lymphocytes by measuring the difference in foci at 30 min and 24 hours after 1Gy radiation of peripheral lymphocytes.

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Countries

Netherlands

Outcome results