- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00566566
Adipokines as Predictors of the Metabolic Syndrome in ALL Survivors
Adipocytokines as Predictors of the Metabolic Syndrome in Survivors of Childhood Acute Lymphoblastic Leukemia
Background: Acute Lymphoblastic Leukemia (ALL) is the most common malignancy in children. It accounts for 25% of all childhood cancers. Peak incidence occurs between 2 to 5 years of age. Modern treatment regimens have improved cure rates from virtually zero (in the 1950's) to current overall survival rates of approximately 80%.The high survival rates have introduced us to novel medical problems as a consequences of the different treatment regimens. No single treatment modality exists today but rather several treatment protocols are accepted worldwide. As such, the population of the childhood ALL survivors differ in their toxic exposure: cranial & spinal radiotherapy, intrathecal and/or systemic chemotherapy and bone marrow transplantation .As the survival rates grow, there are more young adult ALL survivors worldwide susceptible to these late effects of treatment.
Numerous reports have pointed out that this particular group is at increased risk to develop cardiovascular disease (CVD) and diabetes (MS). The metabolic syndrome, i.e hypertension, dyslipidemia, impaired glucose metabolism and obesity, occurs at a younger age than the general population.
Adipocytokines, mediators secreted by adipose tissue, play an important role in the regulation of carbohydrates and lipid metabolism.Changes in serum adipokine levels precede the clinical symptoms.
We aim to identify and assess prevalence of the MS in ALL survivors. We aim to characterize the population at risk to develop DM and CVD prior to overt clinical disease. Characterization will be done by measuring serum adipocytokines and inflammatory cytokine profiles .Biochemical characterization of the group at risk will enable us to intervene in the preventive stage in the future.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Anticipato)
Contatti e Sedi
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
Inclusion Criteria:
- ALL diagnosis
- five years after completion of treatment
- leukemia free during research
Exclusion Criteria:
- ongoing chemotherapy and radiotherapy
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
|---|---|
|
1
ALL survivors 5 years after completion of treatment, during routine medical follow up
|
family history, anthropometric measurements and blood sampling
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Yael Weintraub, MD, Tel Aviv University
Pubblicazioni e link utili
Pubblicazioni generali
- Alberti KG, Zimmet P, Shaw J; IDF Epidemiology Task Force Consensus Group. The metabolic syndrome--a new worldwide definition. Lancet. 2005 Sep 24-30;366(9491):1059-62. doi: 10.1016/S0140-6736(05)67402-8. No abstract available.
- Koerner A, Kratzsch J, Kiess W. Adipocytokines: leptin--the classical, resistin--the controversical, adiponectin--the promising, and more to come. Best Pract Res Clin Endocrinol Metab. 2005 Dec;19(4):525-46. doi: 10.1016/j.beem.2005.07.008.
- Cook S, Weitzman M, Auinger P, Nguyen M, Dietz WH. Prevalence of a metabolic syndrome phenotype in adolescents: findings from the third National Health and Nutrition Examination Survey, 1988-1994. Arch Pediatr Adolesc Med. 2003 Aug;157(8):821-7. doi: 10.1001/archpedi.157.8.821.
- Eckel RH, Grundy SM, Zimmet PZ. The metabolic syndrome. Lancet. 2005 Apr 16-22;365(9468):1415-28. doi: 10.1016/S0140-6736(05)66378-7.
- Taskinen M, Saarinen-Pihkala UM, Hovi L, Lipsanen-Nyman M. Impaired glucose tolerance and dyslipidaemia as late effects after bone-marrow transplantation in childhood. Lancet. 2000 Sep 16;356(9234):993-7. doi: 10.1016/S0140-6736(00)02717-3.
- Gurney JG, Ness KK, Sibley SD, O'Leary M, Dengel DR, Lee JM, Youngren NM, Glasser SP, Baker KS. Metabolic syndrome and growth hormone deficiency in adult survivors of childhood acute lymphoblastic leukemia. Cancer. 2006 Sep 15;107(6):1303-12. doi: 10.1002/cncr.22120.
- Mohn A, Di Marzio A, Capanna R, Fioritoni G, Chiarelli F. Persistence of impaired pancreatic beta-cell function in children treated for acute lymphoblastic leukaemia. Lancet. 2004 Jan 10;363(9403):127-8. doi: 10.1016/S0140-6736(03)15264-6.
- Razzouk BI, Rose SR, Hongeng S, Wallace D, Smeltzer MP, Zacher M, Pui CH, Hudson MM. Obesity in survivors of childhood acute lymphoblastic leukemia and lymphoma. J Clin Oncol. 2007 Apr 1;25(10):1183-9. doi: 10.1200/JCO.2006.07.8709.
- Kourti M, Tragiannidis A, Makedou A, Papageorgiou T, Rousso I, Athanassiadou F. Metabolic syndrome in children and adolescents with acute lymphoblastic leukemia after the completion of chemotherapy. J Pediatr Hematol Oncol. 2005 Sep;27(9):499-501. doi: 10.1097/01.mph.0000181428.63552.e9.
- Oeffinger KC, Buchanan GR, Eshelman DA, Denke MA, Andrews TC, Germak JA, Tomlinson GE, Snell LE, Foster BM. Cardiovascular risk factors in young adult survivors of childhood acute lymphoblastic leukemia. J Pediatr Hematol Oncol. 2001 Oct;23(7):424-30. doi: 10.1097/00043426-200110000-00007.
- Pui CH, Cheng C, Leung W, Rai SN, Rivera GK, Sandlund JT, Ribeiro RC, Relling MV, Kun LE, Evans WE, Hudson MM. Extended follow-up of long-term survivors of childhood acute lymphoblastic leukemia. N Engl J Med. 2003 Aug 14;349(7):640-9. doi: 10.1056/NEJMoa035091. Erratum In: N Engl J Med. 2003 Sep 25;349(13):1299.
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- SHEBA-07-4861-YW-CTIL
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 sample without DNA
-
Hillel Yaffe Medical CenterSconosciuto
-
Amsterdam UMC, location VUmcDutch Kidney Foundation; B.Braun Avitum AG; Niercentrum aan de AmstelNon ancora reclutamentoMalattia renale allo stadio terminale
-
Fudan UniversityReclutamento
-
Marmara UniversityNon ancora reclutamentoIpomineralizzazione molare-incisivo
-
National Institute of Allergy and Infectious Diseases...HIV Vaccine Trials Network; IPPOX Foundation; CHAVI; MHRPCompletato
-
National Institute of Allergy and Infectious Diseases...Completato
-
Dana-Farber Cancer InstituteCompletatoInfezione da HPV | Carcinoma a cellule squamose orofaringeo positivo per HPVStati Uniti
-
Northwell HealthAttivo, non reclutanteCancro pancreatico metastaticoStati Uniti
-
Origin SciencesRoyal Infirmary of EdinburghCompletatoDiagnosi | Malattia della vaginaRegno Unito
-
Chinese University of Hong KongCompletato