Department of Pediatrics and Adolescent Medicine
Erlangen, 91054, Germany
Location status: Recruiting
NCT Number: NCT07705178
In this study, we investigate the cardiopulmonary health of survivors who underwent cancer treatment for acute lymphoblastic leukemia (ALL) or lymphoma during childhood, compared with healthy controls. Modern imaging techniques (MRI, MSOT, and echocardiography) as well as questionnaires assessing cardiopulmonary and mental health are used.
Interested in participating?
Request Info3 year and older
All sexes
Interventional
Not applicable
Erlangen, 91054, Germany
Location status: Recruiting
Survivors of childhood cancer have a high risk of developing late effects regarding different organ systems even years after treatment. Our preliminary data show that a high number of our study participants who have received oncological treatment for ALL or Hodgkin's disease, develop severe ventilation and/or perfusion disorders/defects that can be detected on MRI of the lungs. These changes are mainly observed in participants with a greater interval to the oncological treatment and we could find a significant correlation between ventilation- and perfusion defects and the timespan after diagnosis. In spiroergometry, our patient group showed reduced aerobic capacity (ViO2 max), regardless of the time of follow-up. Echocardiography including strain analysis resulted in suspicious findings. The aim of our follow-up project is to validate these results in a larger patient population and to extend the investigations of long-term follow up after oncological disease/treatment in childhood and adolescence. We are planning to conduct a multicenter study with participants (who received oncological treatment in childhood or adolescence and are now undergoing long-term-follow-up care (> 5 years after treatment,). Therefore, we will examine morphological und functional lung changes by low field strength MRI and spiroergometry. We plan to investigate cardiac changes by echocardiography with strain analysis and ECG. Additionally, we would like to use multispectral optoacoustic tomography (MSOT) screening for muscle atrophy due to peripheral artery disease (PAD) as another modern imaging procedure for early detection of vascular changes.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Control Group:
Inclusion criteria
Exclusion criteria
Survivors of ALL:
Inclusion criteria
Exclusion criteria
Survivors of Lymphoma:
Inclusion criteria
Exclusion criteria
QoL assessment by EORTC SURV100, PPR
During this non-invasive test, the subject must breathe against resistance through a mouthpiece.
DLCO measurement is a non-invasive pulmonary function test for Pulmonary Diffusion Capacity.
Echocardiography with strain-rate imaging.
LF-MRI for detection of morphological and functional changes in the lung and heart.
Recording patient information (Age, Gender, Weight and height, Ethnicity, current medication, measurement of blood pressure and blood oxygen saturation.
Blood samples for further molecular testing regarding epigenetic aging markers and telomere biology parameters.
multispectral optoacoustic tomography of musculus gastrocnemius bilaterally for screening of PAD
Time frame: Single time point
Morphological lung changes
Time frame: Single time point
Ventilation match/mismatch, Perfusion match/mismatch, combined defects
Time frame: Single time point
Quantitative and functional cardiovascular changes of the heart
Time frame: Single time point
diffusing capacity of the lungs for carbon monoxide (absolute value and % of predicted value)
Time frame: Single time point
Alveolar Volume
Time frame: Single time point
DLCO/VA (absolute and % of predicted value)
Time frame: single time point
VC (vital capacity) in %
Time frame: Single time point
FEV1 (Forced Expiratory Volume in 1 Second) in %
Time frame: Single time point
Oxygen uptake (VO2)
Time frame: Single time point
peak oxygen uptake (VO2max)
Time frame: Single time point
Respiratory exchange ratio (RER)
Time frame: Single time point
Ventilatory anaerobic threshold (VT2)
Time frame: Single time point
Carbon dioxide output (VCO2)
Time frame: Single time point
Heart rate (HR)
Time frame: Single time point
Heart Rate Reserve (HRR)
Time frame: Single time point
Breath rate at VAT
Time frame: Single time point
Breath rate reserve (BRR)
Time frame: Single time point
minute ventilation (VE)
Time frame: Single time point
O2 Pulse
Time frame: Single time point
Heart rate variability (HRV)
Time frame: Single time point
Exercise capacity (Borg Scale)
Time frame: Single time point
Myocardial function by echocardiographic strain and strain-rate imaging
Time frame: Single time point
Age in years
Time frame: Single time point
Gender
Time frame: Single time point
Weight
Time frame: Single time point
Ethnicity
Time frame: Single time point
Time from therapy initiation/Interval until study day
Time frame: Single time point
Current medication*
Time frame: Single time point
Secondary diagnoses
Time frame: Single time point
Blood pressure measurement
Time frame: Single time point
Standard clinical examination
Time frame: Single time point
EORTC-SURV100 PPR (Posttraumatische Persönliche Reifung) Adapted Decision Regret questionnaire for childhood cancer survivors
Time frame: Single time point
Presence of clonal hematopoiesis (CH)
Time frame: Single time point
Type of CH-associated gene mutations (e.g. DNMT3A, TET2, DDR genes)
Time frame: Single time point
Clone size / variant allele frequency (VAF)
Time frame: Single time point
Epigenetic aging markers (e.g. epigenetic age acceleration measures)
Time frame: Single time point
Telomere biology parameters (e.g. telomere length-related measures)
Time frame: Single time point
biomarkers for long-term pulmonary dysfunction (WFDC2, TNFR1, MMP2, SPD18)
Time frame: Single time point
Oxygenated haemoglobin (HbO₂)
Time frame: Single time point
Deoxygenated haemoglobin (HHb)
Time frame: Single time point
Total haemoglobin (tHb)
Time frame: Single time point
Tissue oxygen saturation (sO₂)
Time frame: Single time point
MSOT signal intensity per region of interest
Time frame: Single time point
MSOT topogram of perfusion of the m. gastrocnemius
Contact information is provided by the study sponsor or research team.
Axel Karow, PD. Dr. med.
CONTACT
Ferdinand Knieling, Prof. Dr. med.
CONTACT
University of Erlangen-Nürnberg Medical School
Other
"MaximALL" More Than Just X-Rays - Imaging of Chemotherapy-induced Morphological and Functional Cardiovascular and Lung Changes After Childhood ALL and Other Cancers - a Monocentric Late Effects Study (MaximALL)
Acronym: MaximALL
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