- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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.
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
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 di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
-
-
-
Montpellier, Francia, 34295
- Uh Montpellier
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
- 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
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
|---|
|
CCS group
Patients under 25 were recruited in the pediatric CPET laboratory of Montpellier University Hospital after a regular paediatric cardiology outpatient visit.
|
|
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.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
comparison of VO2max for CCS patients compared to control children
Lasso di tempo: 1 day
|
comparison of the mean of VO2max value in ml/kg/min between CCS group and control group
|
1 day
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
comparison of ventilatory anaerobic threshold (VAT) for CCS patients compared to control children
Lasso di tempo: 1 day
|
comparison of the mean of VAT value in ml/kg/min between CCS group and control group
|
1 day
|
|
correlation between clinical determinants and VO2max in the CCS group
Lasso di tempo: 1 day
|
with multivariate analysis, we will look for the correlation between the clinical determinants and the decreased of VO2max in CCS group.
|
1 day
|
Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Arthur GAVOTTO, University Hospital, Montpellier
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- RECHMPL20_0089
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Cancro infantile
-
Zeba Ahmad, Ph.D.American Cancer Society, Inc.ReclutamentoCaregiving for CancerStati Uniti
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)CompletatoAdenocarcinoma dell'intestino tenue | Adenocarcinoma dell'intestino tenue in stadio III AJCC v8 | Adenocarcinoma dell'intestino tenue in stadio IIIA AJCC v8 | Adenocarcinoma dell'intestino tenue in stadio IIIB AJCC v8 | Adenocarcinoma dell'intestino tenue stadio IV AJCC v8 | Ampolla di Vater... e altre condizioniStati Uniti
-
Georgetown UniversityNational Cancer Institute (NCI); American Cancer Society, Inc.; Susan G. Komen...CompletatoStudio delle donne cinesi che non hanno aderito alle linee guida per lo screening mammografico dell'American Cancer SocietyStati Uniti
-
Institut Cancerologie de l'OuestAttivo, non reclutanteQualità della vita al lavoro | Professionisti paramedici | Toccare Massaggio | Cancer CenterFrancia
-
Emory UniversityNational Cancer Institute (NCI)RitiratoCancro al seno in stadio IV prognostico AJCC v8 | Neoplasia maligna metastatica nel cervello | Carcinoma mammario metastatico | Anatomic Stage IV Breast Cancer American Joint Committee on Cancer (AJCC) v8
-
Yonsei UniversityNon ancora reclutamentoRAS/BRAF Wild-Type Advanced Cancer MathementCorea, Repubblica di
-
NRG OncologyNational Cancer Institute (NCI)CompletatoCancro al seno in stadio anatomico IV AJCC v8 | Cancro al seno in stadio IV prognostico AJCC v8 | Neoplasia maligna metastatica nell'osso | Neoplasia maligna metastatica nei linfonodi | Neoplasia maligna metastatica nel fegato | Carcinoma mammario metastatico | Neoplasia maligna metastatica nel... e altre condizioniStati Uniti, Canada, Arabia Saudita, Corea del Sud
-
Jonsson Comprehensive Cancer CenterReclutamentoAdenocarcinoma prostatico | Cancro alla prostata in stadio II AJCC v8 | Fase I Cancro alla prostata American Joint Committee on Cancer (AJCC) v8Stati Uniti
-
Jonsson Comprehensive Cancer CenterNovartis PharmaceuticalsReclutamentoCarcinoma della prostata | Stadio IVB Cancro alla prostata American Joint Committee on Cancer (AJCC) v8Stati Uniti
-
Second Affiliated Hospital, School of Medicine,...Attivo, non reclutanteElettroacopuntura combinata con paclitaxel legato alla proteina e anticorpo PD-1 per il trattamento di seconda linea di HER2 negativo, PMMR/MSS Advanced Gastric CancerCina