ONCOTIPNET: Multicenter Study on Risk Factors and Outcome in Cancer Pediatric Patients Admitted in Italian PICUs
NCT ID: NCT04581655
Last Updated: 2022-07-19
Study Results
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Basic Information
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COMPLETED
500 participants
OBSERVATIONAL
2021-03-01
2022-07-01
Brief Summary
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Detailed Description
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1. characteristics of pediatric cancer patients admitted to Italian PICUs
2. risk factors of PICU admission, neurological outcome and mortality.
Inclusion criteria: age \<= 18 years, informed consent. Exclusion criteria: informed consent not obtained. After a retrospective analysis (2019-2020), investigators will perform a prospective study over 12 months (March 2021 - February 2021) gathering data from 15-20 Italian PICUs. Each Center can decide whether to participate only in the prospective phase. Data will be recorded in an electronic data collection form in Red Cap.
The following variables will be collected:
* Demographic variables: age, sex, ethnicity;
* TIP pre-admission clinical variables and at the time of admission: basic diagnosis, comorbidity, Hemopoietic Stem Cell Transplantation (TCSE) number and type, treatment phase, HLA matching, Graft Versus Host (GVH) and grade, veno-occlusive disease, Venous Occlusive Disease
* Variables upon entering TIP: PIM3, POPC score, organ failure cause and staging, high intensity treatments, high flow oxygen therapy, dialysis, inotropes or other, fluid overload, immunodeficiency
* Clinical variables during hospitalization: organ failure cause and staging, ventilation, modality, presence of pARDS and severity, need for inotropic support, sepsis and severity score (SOFA), inotropes (VIS score), arrest event cardiac, need for HFOV, Extra-Corporeal Membrane Oxygenator, Nitric Oxide, dialysis, Intracranial Pressure monitoring, drugs used for sedation, development of withdrawal syndrome, development of delirium.
Considering the participation of 15-20 centers involving 20 patients in a year, the expected number is 600 patients considering the retrospective phase (optional, therefore some Centers may not contribute) and the prospective phase.
Study sites will also take part to a survey designed to collect data in order to describe Italian PICUs involved in providing care to cancer patients.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* informed consent\*
Exclusion Criteria
* only for next prospective part of the study
18 Years
ALL
No
Sponsors
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University of Padova
OTHER
Azienda Ospedaliera di Padova
OTHER
Responsible Party
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angela amigoni
Principal Investigator
Principal Investigators
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angela amigoni, Dr
Role: PRINCIPAL_INVESTIGATOR
University Hospital Padova
Locations
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Salesi Hospital
Ancona, , Italy
Giovanni XIII Hospital
Bergamo, , Italy
University Hospital Policlinico S.Orsola-IRCCS
Bologna, , Italy
Spedali Civili Hospital, University of Brescia
Brescia, , Italy
I Policlinico
Catania, , Italy
Meyer Hospital
Florence, , Italy
Gaslini Hospital
Genova, , Italy
University of Messina
Messina, , Italy
Children's Hospital V. Buzzi-Sacco
Milan, , Italy
Santobono Hospital
Napoli, , Italy
Azienda Ospedale Università Padova
Padua, , Italy
Di Cristina Hospital
Palermo, , Italy
"Bambino Gesù" Children's Hospital
Roma, , Italy
Regina Margherita Hospital
Torino, , Italy
Burlo Garofalo Hospital
Trieste, , Italy
University Hospital, Verona
Verona, , Italy
S.Bortolo Hospital
Vicenza, , Italy
Countries
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References
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Pillon M, Amigoni A, Contin A, Cattelan M, Carraro E, Campagnano E, Tumino M, Calore E, Marzollo A, Mainardi C, Boaro MP, Nizzero M, Pettenazzo A, Basso G, Messina C. Risk Factors and Outcomes Related to Pediatric Intensive Care Unit Admission after Hematopoietic Stem Cell Transplantation: A Single-Center Experience. Biol Blood Marrow Transplant. 2017 Aug;23(8):1335-1341. doi: 10.1016/j.bbmt.2017.04.016. Epub 2017 Apr 28.
Pillon M, Sperotto F, Zattarin E, Cattelan M, Carraro E, Contin AE, Massano D, Pece F, Putti MC, Messina C, Pettenazzo A, Amigoni A. Predictors of mortality after admission to pediatric intensive care unit in oncohematologic patients without history of hematopoietic stem cell transplantation: A single-center experience. Pediatr Blood Cancer. 2019 Oct;66(10):e27892. doi: 10.1002/pbc.27892. Epub 2019 Jun 28.
Wosten-van Asperen RM, van Gestel JPJ, van Grotel M, Tschiedel E, Dohna-Schwake C, Valla FV, Willems J, Angaard Nielsen JS, Krause MF, Potratz J, van den Heuvel-Eibrink MM, Brierley J; POKER (PICU Oncology Kids in Europe Research group) research consortium. PICU mortality of children with cancer admitted to pediatric intensive care unit a systematic review and meta-analysis. Crit Rev Oncol Hematol. 2019 Oct;142:153-163. doi: 10.1016/j.critrevonc.2019.07.014. Epub 2019 Aug 3.
Faraci M, Bagnasco F, Giardino S, Conte M, Micalizzi C, Castagnola E, Lampugnani E, Moscatelli A, Franceschi A, Carcillo JA, Haupt R. Intensive care unit admission in children with malignant or nonmalignant disease: incidence, outcome, and prognostic factors: a single-center experience. J Pediatr Hematol Oncol. 2014 Oct;36(7):e403-9. doi: 10.1097/MPH.0000000000000048.
Amigoni A, Boscato S, Mondardini MC, Cavagnero F, Marchetto L, Biassoni V, Birolo C, Bottari G, Corno M, Ferrario S, Maiolo G, Montaguti A, Rossetti E, Rulli I, Sagredini R, Spaggiari S, Vatiero L, Vigna G, Martinato M, Gregori D, Pillon M, Comoretto RI; OncoTIPNet Study Group. Exploring risk factors for pediatric cancer patients admitted to the Pediatric Intensive Care Unit: insight from a multicenter observational study revealing no association with mechanical ventilation. J Anesth Analg Crit Care. 2025 Oct 14;5(1):63. doi: 10.1186/s44158-025-00275-6.
Other Identifiers
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ONCOTIPNET
Identifier Type: -
Identifier Source: org_study_id
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