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The study is prematurely terminated due to bad inclusion and the fact that examinations are already being used in standard care.
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| Name | Class |
|---|---|
| Academisch Ziekenhuis Maastricht | OTHER |
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Severe radiation-induced lung injury (RILI) occurs in approximately 20% of the lung cancer patients, who are treated with curative chemoradiation. In this study the investigators want to evaluate the prognostic value of baseline cardiac function assessed with echocardiography for prediction of RILI.
Severe radiation-induced lung injury (RILI) occurs in approximately 20% of the lung cancer patients, who are treated with curative chemoradiation (CRT).This side-effect can heavily impact quality of life and is a dose-limiting factor for the treatment. Identifying high risk patients before the start of the treatment would make it possible to adapt the treatment by choosing another radiation technique or proton therapy. However, despite the fact that many patient and treatment characteristics have been associated with RILI, it is not possible to accurately predict the risk of RILI for individual patients. Recently, it has been shown that the radiation dose to the heart is a risk factor for lung toxicity in both animal and clinical studies. Also, in a study, carried out jointly by CARIM and GROW, it was found that patients with a previous diagnosis of cardiac disease had a significantly higher risk to develop RILI after CRT (p-value <0.001), even with low or no radiation dose to the heart. It is unknown whether asymptomatic cardiac comorbidity is also related to development of RILI. Taking into account that approximately 30% of all lung cancer patients suffer from symptomatic cardiac comorbidity at the start of cancer treatment, there is an urgent need for research projects focusing on cardio-oncology. These projects will make it possible to unravel the complex relationship between heart, lungs, chemotherapy and radiation treatment. In the current project the investigators hypothesize that biomarkers based on echocardiography, which reflects cardiac function, are prognostic for development of radiation induced lung injury after chemoradiotherapy. In addition, the investigators will validate our previous finding that presence of cardiac comorbidity is associated with RILI.
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| Measure | Description | Time Frame |
|---|---|---|
| Dyspnea score at three months after (chemo)radiotherapy, assessed by the patient version of the CTCv4.0 | up to 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Dyspnea score at six months after (chemo)radiotherapy, assessed by the patient version of CTCv4.0 | up to 6 months | |
| Changes in dyspnea score after radiotherapy, compared to baseline | up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiac Comorbidity according to ICD v10 | up to 12 months | |
| Radiomics (the evolving field of texture analysis) of normal tissue(heart and lung) | up to 3 months | |
| Mitochondrial DNA (prognostic value of mtDNA for development of RILI) |
Inclusion Criteria:
Exclusion Criteria:
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All patients referred to MAASTRO Clinic with non-small cell lung cancer stage I-III disease can be included in this study (approximately 160 patients per year).
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| Name | Affiliation | Role |
|---|---|---|
| Dirk De Ruysscher, PhD. | MAASTRO-clinic (senior researcher) | Principal Investigator |
| Bas Kietselaer, MD,Phd | AzM/MUMC (cardiologist) | Principal Investigator |
| Judith van Loon, MD,PhD | MAASTRO-clinic (radiation oncologist) | Principal Investigator |
| Philippe Lambin, Prof,MD,Phd | MAASTRO-clinic (radiation oncologist) | Principal Investigator |
| Anne-Marie Dingemans, MD, PhD | MAASTRO-clinic (pulmonogist) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MAASTRO clinic | Maastricht | Limburg | 6229 ET | Netherlands | ||
| Maastricht University Medical Center |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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Bloodsamples and saliva samples will be collected according to the biobank protocol at Maastro clinic to explore the prognostic value of mitochondrial DNA for development of radiation-induced lung injury.
Cardiac bloodmarkers: B-type Natriuretic Peptide (BNP), cardiac Troponin I and T will be measured.
Haemoglobin and inflammatory parameters (CRP, IL-6 and TNFa)
| Change in Left Ventricle Ejection Fraction (LVEF) (baseline versus 3-month after chemo radiation) | up to 3 months |
| Change in left atrial volume (2009 AHA/ESC guidelines)(baseline versus 3-month after chemo radiation) | up to 3 months |
| Radiation pneumonitis at 3-months after start of radio(chemo)therapy, assessed on a follow-up 3D CT scan image. | up to 3 months |
| Lung fibrosis score at 6-months after start of chemo radiation, assessed on a follow-up CT scan image | up to 6 months |
| Prevalence-based dyspnea measure, reflecting severity as well as duration of dyspnea | up to 12 months |
| Changes in physical activity levels and sedentary behavior, assessed by accelerometry | up to 12 months |
| Pulmonary function based on spirometry | up to 3 months |
| Change in left atrial ejection fraction (from pts in SR)(2009 AHA/ESC guidelines)(baseline versus 3-month after chemo radiation) | up to 3 months |
| Change in mitral inflow (2009 AHA/ESC guidelines)(baseline versus 3-month after chemo radiation) | up to 3 months |
| Change in pulmonary vein inflow patterns (2009 AHA/ESC guidelines)(baseline versus 3-month after chemo radiation) | up to 3 months |
| Change in tissue doppler patterns of the mitral annulus (2009 AHA/ESC guidelines)(baseline versus 3-month after chemo radiation) | up to 3 months |
| Cardiac blood biomarkers at baseline and during treatment, Brain natriuretic peptide(BNP), troponin I (TnI) and troponin T(TnT) | up to 3 months |
| Haemoglobin parameters in the blood at baseline and during treatment | up to 3 months |
| Inflammatory parameters (CRP, IL-6 and TNFa) in the blood at baseline and during treatment | up to 3 months |
| Time trends in physical activity and sedentary time from baseline till 12 months after radiotherapy, measured by accelerometers in four weekly periods | up to 12 months |
| up to 12 months |
| Body composition, analysed by evaluation of muscle mass and fat mass on computed tomography (CT) scans at a standardized vertebral landmark (third lumbar vertebra) | up to 12 months |
| Muscle strength, measured by respiratory mouth pressure measurement, maximum inspiratoire mouthpressure, (Pimax) | up to 12 months |
| arterial inflammation as revealed by 18F-FDG PET . Standardized quantification parameters will be applied: Standardized uptake value (SUV), target-to-background ratio (TBR), most diseased segment analysis | up to 12 months |
| Calcification score of the coronary artery and thoracic aorta. The calcification will be quantified by using fully automated scoring and graded according to the Agatston score method | up to 3 months |
| Maastricht |
| Limburg |
| 6229 HX |
| Netherlands |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |