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

July 18, 2022 updated by: angela amigoni, Azienda Ospedaliera di Padova

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Ancona, Italy
        • Salesi Hospital
      • Bergamo, Italy
        • Giovanni XIII Hospital
      • Bologna, Italy
        • University Hospital Policlinico S.Orsola-IRCCS
      • Brescia, Italy
        • Spedali Civili Hospital, University of Brescia
      • Catania, Italy
        • I Policlinico
      • Firenze, Italy
        • Meyer Hospital
      • Genova, Italy
        • Gaslini Hospital
      • Messina, Italy
        • University of Messina
      • Milano, Italy
        • Children's Hospital V. Buzzi-Sacco
      • Napoli, Italy
        • Santobono Hospital
      • Padova, Italy, 35128
        • Azienda Ospedale Universita Padova
      • Palermo, Italy
        • Di Cristina Hospital
      • Roma, Italy
        • "Bambino Gesù" Children's Hospital
      • Torino, Italy
        • Regina Margherita Hospital
      • Trieste, Italy
        • Burlo Garofalo Hospital
      • Verona, Italy
        • University Hospital, Verona
      • Vicenza, Italy
        • S.Bortolo Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

pediatric patients with cancer disease admitted in PICU

Description

Inclusion Criteria:

  • age <= 18 yeras
  • informed consent*

Exclusion Criteria:

  • informed consent not obtained*

    • only for next prospective part of the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
mortality
Time Frame: from date of patient's admission in PICU to date of PICU discharge assessed up to 7 days
rate of dead patients
from date of patient's admission in PICU to date of PICU discharge assessed up to 7 days
mortality
Time Frame: from discharge to 30th day after PICU discharge
30-days mortality
from discharge to 30th day after PICU discharge
mortality
Time Frame: from 31st to 90th day after PICU discharge
90-days mortality
from 31st to 90th day after PICU discharge
neurological outcome
Time Frame: on date of PICU discharge assessed up to 10 days
patients's Pediatric Overall Performance Category (POPC) score (a 6 level score: 4 to 6 is considered bad outcome)
on date of PICU discharge assessed up to 10 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Ospedaliera di Padova

Collaborators

University of Padova

Investigators

  • Principal Investigator: angela amigoni, Dr, University Hospital Padova

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 1, 2021

Primary Completion (ACTUAL)

April 30, 2022

Study Completion (ACTUAL)

July 1, 2022

Study Registration Dates

First Submitted

September 21, 2020

First Submitted That Met QC Criteria

October 7, 2020

First Posted (ACTUAL)

October 9, 2020

Study Record Updates

Last Update Posted (ACTUAL)

July 19, 2022

Last Update Submitted That Met QC Criteria

July 18, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ONCOTIPNET

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

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)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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