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- Ensaio Clínico NCT04815447
Cardiopulmonary Fitness and Its Clinical Determinants of a Population of Childhood Cancer Survivor (ONCO-SPORT)
Cardiopulmonary Fitness and Its Clinical Determinants of a Population of Childhood Cancer Survivor: a Controlled Retrospective Study
Medical progress have made it possible to considerably improve the survival of children with an oncological disease. Currently, the survival rate increased to above 90 % in the most developed countries . This increase of childhood cancer survivors (CCS) asks us about their future and their quality of life. Assessing health related life quality , previous studies observe that in this particular population of patients, it is related to a poor physical capacity , physical activity level and many of these patients do not meet the activity level recommended by the world health organization due to fatigability and sedentary behaviours . In addition to these habits, the CCS are more susceptible to develop cardiovascular risk (CVR) leading to cardiovascular disease in adulthood and increases them mortality . Furthermore, CCS who have been experiencing hematopoietic stem cells transplantation (HSCT) are more susceptible to develop these CVR. In parallel with the common CVR, lower cardiopulmonary fitness assessed by cardiopulmonary exercise test (CPET) in the general population has been established as a major and independent CVR for cardiologic events.
Cardiopulmonary fitness assessed by maximal cardiopulmonary exercise test (CPET) allows physicians to measure metabolic response to maximal effort in a population that is known as VO2max. This domain of applied physiology permits a new way to approach the understanding of global health prognosis in chronic disease. For example, decrease of VO2max is involved in lower quality of life in patients with congenital heart disease. Cardiopulmonary exercise test for VO2max exploration has been demonstrated feasible in child patients with leukemia or other tumors after intensive chemotherapy, prior to HSCT.
Assessment of cardiopulmonary fitness in CCS is already described in previous studies, but this study aimed to compare a maximal CPET assessment on a large childhood cancer survivors cohort with healthy control, on a quite young cohort, during the oncologic follow up and find out its determinants.
Visão geral do estudo
Status
Condições
Descrição detalhada
This is a controlled, monocentric, cross-sectional study conducted in a tertiary care center for oncologic disease in children (Montpellier University Hospital, France) was carried out between November 2010 and November 2020.
Two groups were identified: CCS group and control group.
Tipo de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
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Montpellier, França, 34295
- UH Montpellier
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
- CCS having been complete a full regimen for oncological disease and considered in remission at the end of treatment
- Controlled children with completely normal check-up, including physical examination, ECG, echocardiography and spirometry
Descrição
Inclusion criteria for CCS group :
- aged between 5 and 25 years old,
- having been complete a full regimen for oncological disease and considered in remission at the end of treatment. Remission was considered in absence of relapse or new treatment initiated before the CPET end point.
Inclusion criteria for control group :
- children referred for a nonsevere functional symptom linked to exercise (murmur, palpitation or dyspnoea) or for a medical sports certificate.
- completely normal check-up, including physical examination, ECG, echocardiography and spirometry.
Exclusion criteria for control group:
- Children with any chronic disease, medical condition (cardiac, neurological, respiratory, muscular or renal)
- Children with any medical treatment
- Children requiring any further specialised medical consultation
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
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CCS group
Patients under 25 were recruited in the pediatric CPET laboratory of Montpellier University Hospital after a regular paediatric cardiology outpatient visit.
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Control
The control group consisted in children referred for a non-severe functional symptom linked to exercise (murmur, palpitation, or dyspnoea) or for a medical sports certificate.
These children were classified in the control group only after a completely normal check-up, including physical examination, electrocardiogram, echocardiography, and spirometry.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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comparison of VO2max for CCS patients compared to control children
Prazo: 1 day
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comparison of the mean of VO2max value in ml/kg/min between CCS group and control group
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1 day
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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comparison of ventilatory anaerobic threshold (VAT) for CCS patients compared to control children
Prazo: 1 day
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comparison of the mean of VAT value in ml/kg/min between CCS group and control group
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1 day
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correlation between clinical determinants and VO2max in the CCS group
Prazo: 1 day
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with multivariate analysis, we will look for the correlation between the clinical determinants and the decreased of VO2max in CCS group.
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1 day
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Arthur GAVOTTO, University Hospital, Montpellier
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- RECHMPL20_0089
Plano para dados de participantes individuais (IPD)
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Descrição do plano IPD
Informações sobre medicamentos e dispositivos, documentos de estudo
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