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| Name | Class |
|---|---|
| Ludwig-Maximilians - University of Munich | OTHER |
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This study aims at investigating the feasibility of recruitment and application of a method regarding early detection of subclinical changes in cardiac health after completion of acute cancer treatment during childhood and adolescence.
Cardiovascular late effects following treatment for pediatric cancer are problematic. Early detection of subclinical changes is hardly possible using conventional diagnostic methods, but seems to be feasible during physical strain (exercise stress echocardiography).
This feasibility study examines as main objective the recruitment strategy and investigation method in 10-25-year olds in the first and fifth year after the end of acute anti-cancer therapy (n=40 participants with a history of childhood cancer and n=40 control subjects). The heart function is examined by means of exercise stress echocardiography and spiroergometry in comparison with healthy age- and gender-matched control subjects.
Secondary aims are the evaluation of aditional echocardiography markers and levels of physical activity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants treated for pediatric cancer | This group includes children, adolescents and young adults treated for pediatric cancer who received anthracyclines and/or chest radiation during treatment. |
| |
| Healthy control subjects | This group includes healthy children, adolescents and young adults without a history of pediatric cancer as age-and gender-matched control subjects. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise stress echocardiography | Diagnostic Test | Study participants perform an exercise stress echocardiography on a semi-supine bicycle ergometer using using a continuous incremental bicycle protocol with a work rate increment every 3 minutes according to gender and weight. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility Criteria 1 - Recruitment Rate | The number of children, adolescents and young adults with a history of pediatric cancer who agree to participate compared to the total number approached for this study. | Throughout study completion, an average of 2 years |
| Feasibility Criteria 2 - Acceptance | Number of finished and discontinued exercise stress echocardiographies. | Throughout study completion, an average of 2 years |
| Feasibility Criteria 3 - Data Quality | Number of evaluable examination data. | Throughout study completion, an average of 2 years |
| Feasibility Criteria 4 - Practicability | Difference between scheduled and required time frame for the single examination. | Throughout study completion, an average of 2 years |
| Feasibility Criteria 5 - Participants' Feedback | Feedback questionnaire with multiple choice options and free text answers. | Throughout study completion, an average of 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Reference Values of Healthy Peers | Assessment of reference values from age- and gender-matched healthy peers (matched pairs). | Throughout study completion, an average of 2 years |
| Analysis of Echocardiography Marker 1 |
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Inclusion criteria for all participants:
Additional inclusion criteria for participants following cancer treatment:
Additional inclusion criteria for healthy control subjects:
- Appropriate as matched pair with respect to age and gender
Exclusion Criteria:
All participants receive a basic physical and cardiological examination at rest as part of the study protocol to ensure capability before performing the exercise stress echocardiography.
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Participants with a history of pediatric cancer will be recruited during appointments in follow-up care at two departments for pediatric cancer in Munich.
Healthy peers will be recruited within social environment of participants with a history of cancer (siblings, close friends) and within schools and sport clubs.
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| Name | Affiliation | Role |
|---|---|---|
| Renate Oberhoffer-Fritz, Prof. Dr. med. | Institute of Preventive Pediatrics, Department of Sport and Health Sciences, TUM | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Preventive Pediatrics, Department of Sport and Health Sciences, Technical University of Munich, Germany | Munich | 80992 | Germany |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D009369 | Neoplasms |
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Deformation Parameters in % (global longitudinal strain and circumferencial strain)
| During the procedure |
| Analysis of Echocardiography Marker 2 | Ejection Fraction (EF) in % | During the procedure |
| Analysis of Echocardiography Marker 3 | M-Mode Parameter | During the procedure |
| Analysis of Echocardiography Marker 4 | Tricuspid Annular Plane Systolic Excursion (TAPSE) in millimeter | During the procedure |
| Analysis of Echocardiography Marker 5 | Left ventricle end diastolic volume (LVEDV) in ml/m² | During the procedure |
| Cardiorespiratory Fitness | Submaximal oxygen uptake VO2peak (ml/kg/min) | During the procedure |
| Physical Activity Level post-therapy | For participants with a history of pediatric cancer: Physical activity questionnaire ActiOn post-therapy for the assessment of the amount of moderate-to-vigorous physical activity. | During the procedure |
| Physical Activity Level in Healthy Control Subjects | For healthy control subjects: Physical activity questionnaire from the KiGGS study (German Health Interview and Examination Survey for Children and Adolescents). | During the procedure |