Odense University Hospital
Odense C, 5000, Denmark
Location status: Recruiting
NCT Number: NCT05258448
Patients with loco-regional NSCLC planned for curative treatment with chemoradiotherapy will be invited to participate in a prospective study; besides routine treatment, the patients will be followed with an ECG and cardiac MR for at least two years after radiotherapy treatment.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Odense C, 5000, Denmark
Location status: Recruiting
Definitive chemo-radiotherapy is the treatment of choice for loco-regional advanced non-small cell lung cancer (LA-NSCLC). However, the treatment is associated with a range of side effects with radiation pneumonitis and esophagitis. In addition, the toxicity of the heart in lung cancer patients treated with radiotherapy has been offered less consideration. Therefore, it is essential to investigate the possible early and late toxicity to the heart and the baseline cardiac status of these patients. This study will describe cardiac comorbidity before radiotherapy treatment by a thorough history. Furthermore, we will evaluate heart function and evaluate possible heart disease by an ECG and cardiac MR. Patients will be followed with ECG and cardiac MR for two years after radiotherapy, detecting structural changes caused by radiotherapy and subclinical disease after radiotherapy.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Cardiac Magnetic Resonance scan and ECG
Time frame: 2 Years
All cause mortality
Time frame: Baseline, at 6, 12 and 24 months.
Change from baseline, evaluated by cardiac MR
Time frame: 2 years.
Assesed by patient interview and review of medical record.
Time frame: 2 years.
Assesed by patient interview and review of medical record
Time frame: At Baseline, 6, 12 and 24 months.
Evaluated by cardiac MR.
Time frame: 2 years
Left ventricular enddiastolic change in cMR
Time frame: 2 years
Left ventricular endsystolic change in cMR
Time frame: 2 years
Left ventricular mass in gram.
Contact information is provided by the study sponsor or research team.
Odense University Hospital
Other
The Effect of Radiotherapy on the Heart in Loco-regional Advanced NSCLC Patients Treated With Definitive Radiotherapy Measured by Cardiac MR
Acronym: COLA
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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