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Pediatric CancerONCOTIPNETNCT04581655

ONCOTIPNET: Multicenter Study on Risk Factors and Outcome in Cancer Pediatric Patients Admitted in Italian PICUs

An observational study of Pediatric Cancer and Critically Ill, run by Azienda Ospedaliera di Padova at 17 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The study will describe characteristics of pediatric cancer patients admitted to Italian PICUs and will analyze risk factors of PICU admission, neurological outcome, and mortality. Read more about this study

Who is it for?
Ages Up to 18 years
Conditions the study is for
Pediatric Cancer, Critically Ill
How many people
500 participants
Where
17 sitesItaly
Study dates
1 Mar 2021to 1 Jul 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Study population: pediatric patients with cancer disease admitted in PICU

Who may be able to join

  • age <= 18 yeras
  • informed consent*

Who cannot join

  • informed consent not obtained*
  • only for next prospective part of the study

Trial locations and contacts

17 sites in 1 country.

17 sites in 1 country

Italy17 sites

  • Salesi Hospital

    Ancona

  • Giovanni XIII Hospital

    Bergamo

  • University Hospital Policlinico S.Orsola-IRCCS

    Bologna

  • Spedali Civili Hospital, University of Brescia

    Brescia

  • I Policlinico

    Catania

  • Meyer Hospital

    Florence

  • Gaslini Hospital

    Genova

  • University of Messina

    Messina

  • Children's Hospital V. Buzzi-Sacco

    Milan

  • Santobono Hospital

    Naples

  • Azienda Ospedale Università Padova

    Padova, 35128

  • Di Cristina Hospital

    Palermo

  • "Bambino Gesù" Children's Hospital

    Roma

  • Regina Margherita Hospital

    Torino

  • Burlo Garofalo Hospital

    Trieste

  • University Hospital, Verona

    Verona

  • S.Bortolo Hospital

    Vicenza

Other trials in Italy

About this study

Official title: Retrospective and Prospective Analysis of Risk and Outcome Factors in Oncohematological Patients Admitted to Italian Pediatric Intensive Care Units: a Multicenter Study

The study will describe characteristics of pediatric cancer patients admitted to Italian PICUs and will analyze risk factors of PICU admission, neurological outcome, and mortality. After a retrospective analysis (2019-2020), investigators will perform a prospective study over 12 months gathering data from 15-20 Italian PICUs.

Read the detailed description

The study aim to evaluate:

  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.

Keywords
pediatric intensive care unit, oncology
Medical subject headings
Neoplasms, Critical Illness

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. mortality

    rate of dead patients

    Measured: from date of patient's admission in PICU to date of PICU discharge assessed up to 7 days

  2. mortality

    30-days mortality

    Measured: from discharge to 30th day after PICU discharge

  3. mortality

    90-days mortality

    Measured: from 31st to 90th day after PICU discharge

  4. neurological outcome

    patients's Pediatric Overall Performance Category (POPC) score (a 6 level score: 4 to 6 is considered bad outcome)

    Measured: on date of PICU discharge assessed up to 10 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Oct 2020
  2. Study start1 Mar 2021
  3. Primary completion30 Apr 2022
  4. Study completion1 Jul 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
500 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04581655
Sponsor's protocol ID
ONCOTIPNET
Acronym
ONCOTIPNET
Status last verified
Jul 2022
First submitted
21 Sep 2020
Last updated
19 Jul 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: We will share individual participant data set with participating centers. Moreover we will share: Study Protocol, Statistical Analysis Plan (SAP), Informed Consent Form (ICF), Clinical Study Report (CSR)

Publications

  • 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.

    PubMed 28461212

  • 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.

    PubMed 31250548

  • 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.

    PubMed 31404827

  • 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.

    PubMed 24276033

  • 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.

    PubMed 41088488

Questions about this trial

What is this clinical trial studying?

An observational study of Pediatric Cancer and Critically Ill, run by Azienda Ospedaliera di Padova at 17 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

mortality (time frame: from date of patient's admission in PICU to date of PICU discharge assessed up to 7 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04581655, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2022.

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