An interventional study of QOL assessment, Neuropsychological and Spirometry in Acute Lymphatic Leukemia and Lymphoma, sponsored by University of Erlangen-Nürnberg Medical School. Recruiting at 1 site in Germany. Open to participants aged 3 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-15.
Sponsored by University of Erlangen-Nürnberg Medical School · Not applicable, Interventional, and Diagnostic
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.
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.
Control Group:
Inclusion Criteria:
Exclusion Criteria:
Survivors of ALL:
Inclusion Criteria:
Exclusion Criteria:
Survivors of Lymphoma:
Inclusion Criteria:
Exclusion Criteria:
Healthy individuals with no previous cancer diagnosis. Volunteers will receive physical examination, standardized pulmonary function testing including spirometry and assessment of the diffusing capacity of the lung for carbon monoxide (DLCO) using a single-breath technique and MRI on a low field system (Lung and heart). Furthermore, cardiopulmonary testing (spiroergometry and echocardiography) is performed.
Diagnostic Test: Spirometry · Diagnostic Test: DLCO measurement · Diagnostic Test: Echocardioraphy · Diagnostic Test: MRI · Other: Clinical parameters
Survivors of treatment for acute lymphatic leukemia in childhood or adolescence. Participants will receive physical examination, standardized pulmonary function testing including spirometry and assessment of the diffusing capacity of the lung for carbon monoxide (DLCO) using a single-breath technique and MRI on a low field system (Lung and heart). Furthermore, cardiopulmonary testing (spiroergometry and echocardiography) and multispectral optoacoustic tomography (MSOT) for Peripheral artery disease (PAD) are performed. compliant data storage). In addition, venous blood samples will be taken for the analysis of molecular biomarkers.
Other: QOL assessment, Neuropsychological · Diagnostic Test: Spirometry · Diagnostic Test: DLCO measurement · Diagnostic Test: Echocardioraphy · Diagnostic Test: MRI · Other: Clinical parameters · Diagnostic Test: Blood samples · Diagnostic Test: MSOT
Survivors of treatment for lymphoma in childhood or adolescence. Participants will receive physical examination, standardized pulmonary function testing including spirometry and assessment of the diffusing capacity of the lung for carbon monoxide (DLCO) using a single-breath technique and MRI on a low field system (Lung and heart). Furthermore, cardiopulmonary testing (spiroergometry and echocardiography) and multispectral optoacoustic tomography (MSOT) for Peripheral artery disease (PAD) are performed. compliant data storage). In addition, venous blood samples will be taken for the analysis of molecular biomarkers.
Other: QOL assessment, Neuropsychological · Diagnostic Test: Spirometry · Diagnostic Test: DLCO measurement · Diagnostic Test: Echocardioraphy · Diagnostic Test: MRI · Other: Clinical parameters · Diagnostic Test: Blood samples · Diagnostic Test: MSOT
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
Morphological lung changes (MRI)
Morphological lung changes
Time frame: Single time point
Functional lung parameters (MRI)
Ventilation match/mismatch, Perfusion match/mismatch, combined defects
Time frame: Single time point
Quantitative and functional cardiovascular changes (MRI)
Quantitative and functional cardiovascular changes of the heart
Time frame: Single time point
DLCO
diffusing capacity of the lungs for carbon monoxide (absolute value and % of predicted value)
Time frame: Single time point
VA
Alveolar Volume
Time frame: Single time point
KCO
DLCO/VA (absolute and % of predicted value)
Time frame: Single time point
VC
VC (vital capacity) in %
Time frame: single time point
FEV1
FEV1 (Forced Expiratory Volume in 1 Second) in %
Time frame: Single time point
VO2
Oxygen uptake (VO2)
Time frame: Single time point
VO2max
peak oxygen uptake (VO2max)
Time frame: Single time point
RER
Respiratory exchange ratio (RER)
Time frame: Single time point
VT2
Ventilatory anaerobic threshold (VT2)
Time frame: Single time point
VCO2
Carbon dioxide output (VCO2)
Time frame: Single time point
HR
Heart rate (HR)
Time frame: Single time point
HRR
Heart Rate Reserve (HRR)
Time frame: Single time point
Breath rate at VAT
Breath rate at VAT
Time frame: Single time point
BRR
Breath rate reserve (BRR)
Time frame: Single time point
VE
minute ventilation (VE)
Time frame: Single time point
O2 Pulse
O2 Pulse
Time frame: Single time point
HRV
Heart rate variability (HRV)
Time frame: Single time point
Borg Scale
Exercise capacity (Borg Scale)
Time frame: Single time point
Echocardiography
Myocardial function by echocardiographic strain and strain-rate imaging
Time frame: Single time point
Clinical parameters 1
Age in years
Time frame: Single time point
Clinical parameters 2
Gender
Time frame: Single time point
Clinical parameters 3
Weight
Time frame: Single time point
Clinical parameters 4
Ethnicity
Time frame: Single time point
Clinical parameters 5
Time from therapy initiation/Interval until study day
Time frame: Single time point
Clinical parameters 6
Current medication\*
Time frame: Single time point
Clinical parameters 7
Secondary diagnoses
Time frame: Single time point
Blood pressure
Blood pressure measurement
Time frame: Single time point
Clinical examination
Standard clinical examination
Time frame: Single time point
Questionnaire regarding psychosocial aspects
EORTC-SURV100 PPR (Posttraumatische Persönliche Reifung) Adapted Decision Regret questionnaire for childhood cancer survivors
Time frame: Single time point
Blood samples 1
Presence of clonal hematopoiesis (CH)
Time frame: Single time point
Blood samples 2
Type of CH-associated gene mutations (e.g. DNMT3A, TET2, DDR genes)
Time frame: Single time point
Blood samples 3
Clone size / variant allele frequency (VAF)
Time frame: Single time point
Blood samples 4
Epigenetic aging markers (e.g. epigenetic age acceleration measures)
Time frame: Single time point
Blood samples 5
Telomere biology parameters (e.g. telomere length-related measures)
Time frame: Single time point
Blood samples 6
biomarkers for long-term pulmonary dysfunction (WFDC2, TNFR1, MMP2, SPD18)
Time frame: Single time point
MSOT 1
Oxygenated haemoglobin (HbO₂)
Time frame: Single time point
MSOT 2
Deoxygenated haemoglobin (HHb)
Time frame: Single time point
MSOT 3
Total haemoglobin (tHb)
Time frame: Single time point
MSOT 4
Tissue oxygen saturation (sO₂)
Time frame: Single time point
MSOT 5
MSOT signal intensity per region of interest
Time frame: Single time point
MSOT 6
MSOT topogram of perfusion of the m. gastrocnemius
Time frame: Single time point
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — The raw, individual and identifiable patient data are protected and are not available due to data privacy laws. Further data sets are planned to be shared
Supporting information: Study protocol, Sap
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University of Erlangen-Nürnberg Medical School