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| ID | Type | Description | Link |
|---|---|---|---|
| DKS 2025.17 | Other Grant/Funding Number | Deutsche Kinderkrebsstiftung | |
| 2026-03 | Other Grant/Funding Number | Verein zur Förderung des Tumorzentrums und des CCC Erlangen-EMN der Universität Erlangen-Nürnberg e.V. |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | Other | 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. |
|
| Survivors of leukemia | Other | 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. |
|
| Survivors of lymphoma | Other | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QOL assessment, Neuropsychological | Other | QoL assessment by EORTC SURV100, PPR |
|
| Measure | Description | Time Frame |
|---|---|---|
| Morphological lung changes (MRI) | Morphological lung changes | Single time point |
| Functional lung parameters (MRI) | Ventilation match/mismatch, Perfusion match/mismatch, combined defects | Single time point |
| Quantitative and functional cardiovascular changes (MRI) | Quantitative and functional cardiovascular changes of the heart | Single time point |
| Measure | Description | Time Frame |
|---|---|---|
| DLCO | diffusing capacity of the lungs for carbon monoxide (absolute value and % of predicted value) | Single time point |
| VA | Alveolar Volume |
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Control Group:
Inclusion Criteria:
Exclusion Criteria:
Survivors of ALL:
Inclusion Criteria:
Exclusion Criteria:
Survivors of Lymphoma:
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Axel Karow, PD. Dr. med. | Contact | 09131 8533118 | axel.karow@uk-erlangen.de | |
| Ferdinand Knieling, Prof. Dr. med. | Contact | 09131 8533118 | ferdinand.knieling@uk-erlangen.de |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Pediatrics and Adolescent Medicine | Recruiting | Erlangen | 91054 | Germany |
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
Beginning 9 months and ending 36 months following article publication
The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request as follows:
Individual participant data will not be available Study Protocol and Statistical Analysis Plan will be available The data will be available beginning 9 months and ending 36 months following article publication.
The data will be available to researchers who provide a methodologically sound proposal.
The data will be available for individual participant data meta-analysis, only. Proposals may be submitted up to 36 months following article publication. After 36 months the data will be available in our University's data warehouse but without investigator support other than deposited metadata. Information regarding submitting proposals and accessing data may be found at https://www.uk-erlangen.de.
Restrictions may apply due to patient privacy and the General Data Protection Regulation.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 7, 2026 | Jul 9, 2026 |
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|
| Spirometry | Diagnostic Test | During this non-invasive test, the subject must breathe against resistance through a mouthpiece. |
|
| DLCO measurement | Diagnostic Test | DLCO measurement is a non-invasive pulmonary function test for Pulmonary Diffusion Capacity. |
|
| Echocardioraphy | Diagnostic Test | Echocardiography with strain-rate imaging. |
|
| MRI | Diagnostic Test | LF-MRI for detection of morphological and functional changes in the lung and heart. |
|
| Clinical parameters | Other | Recording patient information (Age, Gender, Weight and height, Ethnicity, current medication, measurement of blood pressure and blood oxygen saturation. |
|
| Blood samples | Diagnostic Test | Blood samples for further molecular testing regarding epigenetic aging markers and telomere biology parameters. |
|
| MSOT | Diagnostic Test | multispectral optoacoustic tomography of musculus gastrocnemius bilaterally for screening of PAD |
|
| Single time point |
| KCO | DLCO/VA (absolute and % of predicted value) | Single time point |
| VC | VC (vital capacity) in % | single time point |
| FEV1 | FEV1 (Forced Expiratory Volume in 1 Second) in % | Single time point |
| VO2 | Oxygen uptake (VO2) | Single time point |
| VO2max | peak oxygen uptake (VO2max) | Single time point |
| RER | Respiratory exchange ratio (RER) | Single time point |
| VT2 | Ventilatory anaerobic threshold (VT2) | Single time point |
| VCO2 | Carbon dioxide output (VCO2) | Single time point |
| HR | Heart rate (HR) | Single time point |
| HRR | Heart Rate Reserve (HRR) | Single time point |
| Breath rate at VAT | Breath rate at VAT | Single time point |
| BRR | Breath rate reserve (BRR) | Single time point |
| VE | minute ventilation (VE) | Single time point |
| O2 Pulse | O2 Pulse | Single time point |
| HRV | Heart rate variability (HRV) | Single time point |
| Borg Scale | Exercise capacity (Borg Scale) | Single time point |
| Echocardiography | Myocardial function by echocardiographic strain and strain-rate imaging | Single time point |
| Clinical parameters 1 | Age in years | Single time point |
| Clinical parameters 2 | Gender | Single time point |
| Clinical parameters 3 | Weight | Single time point |
| Clinical parameters 4 | Ethnicity | Single time point |
| Clinical parameters 5 | Time from therapy initiation/Interval until study day | Single time point |
| Clinical parameters 6 | Current medication* | Single time point |
| Clinical parameters 7 | Secondary diagnoses | Single time point |
| Blood pressure | Blood pressure measurement | Single time point |
| Clinical examination | Standard clinical examination | Single time point |
| Questionnaire regarding psychosocial aspects | EORTC-SURV100 PPR (Posttraumatische Persönliche Reifung) Adapted Decision Regret questionnaire for childhood cancer survivors | Single time point |
| Blood samples 1 | Presence of clonal hematopoiesis (CH) | Single time point |
| Blood samples 2 | Type of CH-associated gene mutations (e.g. DNMT3A, TET2, DDR genes) | Single time point |
| Blood samples 3 | Clone size / variant allele frequency (VAF) | Single time point |
| Blood samples 4 | Epigenetic aging markers (e.g. epigenetic age acceleration measures) | Single time point |
| Blood samples 5 | Telomere biology parameters (e.g. telomere length-related measures) | Single time point |
| Blood samples 6 | biomarkers for long-term pulmonary dysfunction (WFDC2, TNFR1, MMP2, SPD18) | Single time point |
| MSOT 1 | Oxygenated haemoglobin (HbO₂) | Single time point |
| MSOT 2 | Deoxygenated haemoglobin (HHb) | Single time point |
| MSOT 3 | Total haemoglobin (tHb) | Single time point |
| MSOT 4 | Tissue oxygen saturation (sO₂) | Single time point |
| MSOT 5 | MSOT signal intensity per region of interest | Single time point |
| MSOT 6 | MSOT topogram of perfusion of the m. gastrocnemius | Single time point |
| Prot_000.pdf |
| ID | Term |
|---|---|
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D013147 | Spirometry |
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D012129 | Respiratory Function Tests |
| D003948 | Diagnostic Techniques, Respiratory System |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
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