- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04433871
COVID-19 in Pediatric Oncology and Hematology Centers in France (PEDONCOVID)
National SFCE Cohort of SARS-CoV-2 Infections (COVID-19) in Pediatric Oncology and Hematology
Study Overview
Status
Intervention / Treatment
Detailed Description
Since the description of the first cases in December 2019, the world is facing the emergence of a new coronavirus called "severe acute respiratory syndrome coronavirus 2" (SARS-CoV-2), which is responsible for an infectious disease mainly with respiratory manifestation and potently severe or even lethal, named coronavirus disease 2019 (COVID-19) (N. Zhu et al. 2020; Huang et al. 2020). The global spread of this virus led to the development of an unprecedented pandemic with an huge impact on public health and from a social and economic point of view (Ayittey et al. 2020).
First published data mainly concerned the adult population with a detailed COVID-19 clinical description. Few data are available in children. However, the first studies suggest that children may be at a lower risk than adults of developing a severe form of COVID-19 (Guan et al. 2020; Lu et al. 2020; Sinha et al. 2020). Neonatal presentation may be more severe (H. Zhu et al. 2020). Children seem to present with similar symptoms compared with adults but often with a milder form (Cao et al. 2020). Radiological findings also appear to be similar to those in adults (Liu et al. 2020; Xia et al. 2020). Children may be asymptomatic and may participate in the spread of SARS-CoV-2 (Lu et al. 2020; Chan et al. 2020). Nevertheless, severe COVID-19 forms were described in children, even if deaths remain extremely rare (Sun et al. 2020; Lu et al. 2020). Among the previous described severe forms, one of the patient dependent on mechanic ventilation had acute lymphoblastic leukemia (Sun et al. 2020). The publication of Lu et al. probably refers to this patient and it appears that this patient was receiving a maintenance treatment (Lu et al. 2020). This patient presented a co-infection with influenza virus, which probably explained his aggravation (Sun et al. 2020).
To describe COVID-19 presentation in children, adolescent and young adults, this study will include all patients with the following criteria:
- Patient followed-up in any French pediatric oncology and hematology center for a cancer or a benign tumor treated with chemotherapy, radiotherapy or a targeted therapy and with an oncologic treatment ongoing or terminated within the last 6 months, or with an hematopoietic stem cell transplantation history with an immunosuppressive treatment ongoing or terminated within the last 6 months, or a CAR-T cell therapy history
AND
- PCR or serologically-confirmed SARS-CoV-2 infection
OR
-Clinical and radiological diagnosis of SARS-CoV-2 infection with the following criteria : At least two of the following signs (three if no history of contact with an individual with a confirmed COVID-19): fever, cough, loss of smell, loss of taste, myalgia, chest pain, breath shortness, rhinorrhea, acute respiratory signs, diarrhea, headache, recent lethargy, skin rash.
AND
- At least one abnormality compatible with COVID-19 on a chest computed tomography scan.
In all included patients, the following informations will be retrieved from their medical record :
- socio-demographic and anthropometric data: age, sex, weight, height...
- cancer history: type of cancer, severity, ongoing or 30-days past oncologic treatment, significant oncologic treatment with potent impact on COVID-19 evolution (lung surgery, lung radiotherapy...)
- clinical symptoms at initial stage, at 10-15, 15-20, 20-30 days of evolution
- biological signs at initial stage, at 10-15, 15-20, 20-30 days of evolution
- radiological signs at initial stage and on the following exams
- COVID-19 management data: oxygen, antiviral agents, antibiotics...
- Evolutive data: resolution/aggravation of infection, potent sequelae...
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Jérémie M Rouger-Gaudichon, MD, PhD
- Phone Number: +33231064488
- Email: rouger-j@chu-caen.fr
Study Locations
-
-
-
Caen, France, 14033
- Recruiting
- Jérémie Rouger-Gaudichon
-
Contact:
- Jérémie M Rouger-Gaudichon, MD, PhD
- Phone Number: 0231064488
- Email: rouger-j@chu-caen.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- opposition of the patient or of the parents
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Oncologic data
Time Frame: through study completion, an average of 1 year
|
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
Time Frame: through study completion, an average of 1 year
|
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
Time Frame: through study completion, an average of 1 year
|
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
Time Frame: through study completion, an average of 1 year
|
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
Time Frame: through study completion, an average of 1 year
|
chest X-rays and/or CT-scan description if performed
|
through study completion, an average of 1 year
|
COVID-19 management
Time Frame: through study completion, an average of 1 year
|
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
Time Frame: through study completion, an average of 1 year
|
type of sequelae if any
|
through study completion, an average of 1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jérémie Rouger-Gaudichon, MD, PhD, University Hospital of Caen
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20-065
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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