COVID-19 in Pediatric Oncology and Hematology Centers in France

NCT04433871 | Unknown DMC

• 1 other identifier: 20-065
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

Since the description of the first cases of infection in December 2019 in the Hubei province in China, a new coronavirus, called SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2), emerged and caused a pandemic. This new virus is responsible for an infectious disease with respiratory and potent severe symptoms, called COVID-19 (coronavirus disease 2019). The first data concerned essentially the adult population and gave a clinical description of the disease. However, data is missing in the pediatric population. The first published studies indicate that children seem to have a lower risk to get a severe form of COVID-19. Except the case of a child with leukemia recently described with the diagnosis of COVID-19, there is currently no data about pediatric patients with an oncology history or under chemotherapeutic drugs. Cancers are rare among children and is estimated to concern about 1700 new cases in a year in France. Malignant tumor or its treatment can affect self-immunity, which could favor SARS-CoV-2 infection or its aggravation. Thus, the investigators propose in this study to collect data about French children with a cancer and diagnosed with COVID-19.The analysis of the collected data will refine clinical characteristics of SARS-CoV-2 infection in this population. It will be critical for elaborating recommendations for the management of COVID-19 in children with cancer.

Conditions

Covid-19; Cancer

Keywords

child

Outcome Measures

Primary Outcomes (7)

• Oncologic data

  Type of cancer and/or underlying pathologies, oncologic treatments administrated before COVID-19 diagnosis.

  through study completion, an average of 1 year

• COVID-19 diagnosis

  Date of COVID-19 diagnosis, method of diagnosis (PCR and/or clinical signs and/or serology)

  through study completion, an average of 1 year

• Clinical signs

  Description of clinical signs at initial phase, days 7-10, days 15-20 and days 25-30

  through study completion, an average of 1 year

• Biological signs

  Description of biological signs at initial phase, days 7-10, days 15-20 and days 25-30

  through study completion, an average of 1 year

• Radiological signs

  chest X-rays and/or CT-scan description if performed

  through study completion, an average of 1 year

• COVID-19 management

  Management in hospital or at home, use of specific drugs against SARS-CoV2, oxygen required or not, other drugs administrated to manage infection complications.

  through study completion, an average of 1 year

• Potent COVID-19 sequelae

  type of sequelae if any

  through study completion, an average of 1 year

Interventions

No intervention, observational OTHER

No intervention, observational

Eligibility Criteria

• Age: 1 Month - 30 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Children or young adult with a recent oncologic history diagnosed with COVID-19.

You may qualify if:

• Children and parents or adult patient informed AND
• Patient followed-up in a French SFCE pediatric oncology and/or hematology center AND
• Patient followed-up for a cancer or a benign tumor treated with chemotherapy, radiotherapy or targeted therapy and an oncologic treatment ongoing or terminated less than 6 months ago, or patient with an history of hematopoietic stem cells transplantation with immunosuppressive treatment ongoing or terminated less than 6 month ago, or patient with history of CAR-T cell therapy AND
• SARS-CoV-2 infection confirmed by PCR or IgM positivity OR
• Compatible diagnosis of SARS-CoV-2 infection without biological confirmation if: 1- presence of at least two of the following clinical signs if any contact with a COVID+ subject or three of the following clinical signs in case of no such contact: fever, cough, taste or smell abnormality, myalgia, rhinorrhea, diarrhea, respiratory acute signs, recent fatigue, rash, chest pain. AND
• At least one chest CT-scan abnormality compatible with COVID-19

You may not qualify if:

• opposition of the patient or of the parents

Sponsors & Collaborators

• University Hospital, Caen: lead

Study Sites (1)

Jérémie Rouger-Gaudichon

Caen, 14033, France

RECRUITING

MeSH Terms

Conditions

COVID-19; Neoplasms

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Jérémie Rouger-Gaudichon, MD, PhD

  University Hospital of Caen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jérémie M Rouger-Gaudichon, MD, PhD

CONTACT

+33231064488; rouger-j@chu-caen.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2020
• First Posted: June 16, 2020
• Study Start: April 27, 2020
• Primary Completion: April 27, 2022
• Study Completion: April 27, 2023
• Last Updated: June 16, 2020

Record last verified: 2020-04

Locations

FR (1)