Detailed assessment of the baseline cardiovascular risk and status (anthropometric data,
physical status assessment, psychological and quality-of-life questionnaire,
questionnaires on morbidity and cancer-related fatigue, 12-lead ECG, laboratory
parameters, body composition, coronary CT, echocardiography and cardiac MR scan).
In addition to the conventional echocardiographic and cardiac MR parameters, the
investigators also aimed to determine myocardial deformation, i.e. strain (Medis Suite
QStrain) and T1 and T2 mapping values and late-type contrast enhancement and to
investigate their prognostic role. To determine late-type contrast accumulation and to
determine ECV (extracellular volume), patients will be given Gadovis contrast media.
At the same time as the cardiac MR scan (V0 and V4), a serum blood sample will be taken
from the patients, from which the markers below will be measured. These markers are
proteins or molecules that potentially play an important role in the development of
tumour cachexia. The investigators aim to determine the prognostic significance of these
parameters. (Myostatin, IGF-1 (Insulin-like Growth Factor 1), GDF-15 (Growth
Differentiation Factor 15), IL-6 (Interleukin-6).
Patients are followed up for cardiovascular complications during anti-tumour treatment
and are taken into care.
Patients will be assessed at first presentation, after neoadjuvant treatment, immediately
before surgery, in the third week after surgery and in the 3rd, 6th, 9th, 12th
postoperative months. Further follow-up is done by outpatient examination, by telephone
or e-mail and through the eHealth system of Hungary (EESZT) until the end of the 3rd
year.
Patient education:
The detailed patient information leaflet was prepared by the doctors involved in the
development of the protocol at Semmelweis University.
Data storage and data protection:
Patients enrolled in the study will be given a unique identifier after enrolment. Only
this unique identifier will be used in the research record, so the record will not be
directly linked to the patient. No unique identifier (name, place and date of birth,
clinical triage number, social security number, ID card number, etc.) will be included in
the research form. A separate, locked document will be used to link the unique identifier
to the patient. The system-generated unique identifier code is recorded by the clinician
on paper, complete with name, social security number and patient´s social security
number, prior to the first data entry. The same document contains the patient´s informed
consent for the use of the data for scientific purposes. The database and the information
and consent forms, including the patient´s signature, are stored by the institute
coordinators.
Statistical methods:
Using TIBCO Statistica™ 13.4 software, the normality of continuous variables is tested
using the Kolmogorov-Szmirnov test. A two-sample t-test is used for normal distribution
assuming a two-tailed distribution and a one-tailed distribution for selected variables
(Mandard Score for tumour regression). For variables with non-normal distribution, a
Mann-Whitney U test is used as a non-parametric test. Long-term survival data are
analysed using Kaplan-Meyer analysis and log rank test.The level of significance is set
at p<0.05
Ethical requirements
The research design was drawn up in accordance with current legislation and the World
Medical Assotiation´s Declaration of Helsinki.