Covid-19PEDONCOVIDNCT04433871
COVID-19 in Pediatric Oncology and Hematology Centers in France
An observational study of Covid-19 and Cancer, run by University Hospital, Caen at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 month to 30 years
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- 27 Apr 2020to 27 Apr 2023
- How long will I take part?
- 3 Years
- 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 1 month to 30 years
- All sexes
- Child, Adult
Study population: Children or young adult with a recent oncologic history diagnosed with COVID-19.
Who may be able to join
- 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
Who cannot join
- opposition of the patient or of the parents
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Jérémie Rouger-Gaudichon
Caen, 14033
Jérémie M Rouger-Gaudichon, MD, PhD, 0231064488, rouger-j@chu-caen.fr
About this study
Official title: National SFCE Cohort of SARS-CoV-2 Infections (COVID-19) in Pediatric Oncology and Hematology
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.
Read the 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...
- Being tested
- No intervention, observational
- Keywords
- child
- Medical subject headings
- COVID-19, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention, observationalOther
No intervention, observational
What is being measured
The primary outcome is the main question the study is designed to answer.
Oncologic data
Type of cancer and/or underlying pathologies, oncologic treatments administrated before COVID-19 diagnosis.
Measured: 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)
Measured: 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
Measured: 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
Measured: through study completion, an average of 1 year
Radiological signs
chest X-rays and/or CT-scan description if performed
Measured: 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.
Measured: through study completion, an average of 1 year
Potent COVID-19 sequelae
type of sequelae if any
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2020
- Study start27 Apr 2020
- Primary completion27 Apr 2022 (estimated)
- Study completion27 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid-19Studies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 300 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jérémie Rouger-Gaudichon, MD, PhD, Principal investigator, University Hospital of Caen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04433871
- Sponsor's protocol ID
- 20-065
- Acronym
- PEDONCOVID
- Status last verified
- Apr 2020
- First submitted
- 24 Apr 2020
- Last updated
- 16 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National SFCE Cohort of SARS-CoV-2 Infections (COVID-19) in Pediatric Oncology and Hematology
- ClinicalTrials.gov ID
- NCT04433871
- Acronym / sponsor ID
- PEDONCOVID / 20-065
- Keywords
- child
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 27 Apr 2020 (actual)
- Primary completion
- 27 Apr 2022 (estimated)
- Study completion
- 27 Apr 2023 (estimated)
- First posted
- 16 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 1 month to 30 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Children or young adult with a recent oncologic history diagnosed with COVID-19.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- opposition of the patient or of the parents
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention, observationalNo intervention, observational | Other | – |
Primary outcome
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.
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)
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
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
Radiological signs
Time frame: through study completion, an average of 1 year
chest X-rays and/or CT-scan description if performed
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.
Potent COVID-19 sequelae
Time frame: through study completion, an average of 1 year
type of sequelae if any
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jérémie Rouger-Gaudichon, MD, PhD principal investigator
University Hospital of Caen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid-19 and Cancer, run by University Hospital, Caen at 1 site in France.
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 6 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 16 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jérémie M Rouger-Gaudichon, MD, PhD (+33231064488, rouger-j@chu-caen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oncologic data (time frame: through study completion, an average of 1 year). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Jun 2020.