Covid19NCT04374838
Effect of COVID-19 Pandemic on Pediatric Cancer Care
An observational study of Covid19, run by South Egypt Cancer Institute at 1 site in Egypt.
Trial summary
Observational cohort study to assess the effects of COVID19 on pediatric cancer care in Egypt and the Arab World through a survey applied to pediatric oncologists who will be interviewed either directly or through the internet to assess the effect of COVID 19 on pediatric cancer care Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Covid19
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 15 May 2020to 1 Sep 2021
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Pediatric oncologists working in cancer centers in Egypt and the Arab world will be interviewed either directly or through the internet to assess the effect of COVID 19 on pediatric cancer care
Who may be able to join
- Pediatric oncologists working in cancer centers in Egypt and the Arab world during COVID 19 pandemic
Who cannot join
- Pediatric oncologists not caring for patients during COVID 19 pandemic
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
South Egypt Cancer Institute, Assiut University
Asyut, 71515
Mahmoud M Elzembely, MD, 00201146703107, elzimbily@aun.edu.eg
About this study
Observational cohort study to assess the effects of COVID19 on pediatric cancer care in Egypt and the Arab World through a survey applied to pediatric oncologists who will be interviewed either directly or through the internet to assess the effect of COVID 19 on pediatric cancer care
Read the detailed description
Corona viruses are single stranded enveloped RNA viruses with helical capsids. They infect wide variety of hosts including humans and animals. Coronavirus disease 2019 (COVID-19) was first described in December 2019 in Wuhan, the capital of China's Hubei province. A novel corona virus named severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) was identified as the causative organism. On 30 Jan 2020, WHO declared COVID-19 as a Public Health Emergency of International Concern (PHEIC). Subsequently on 11 March 2020, WHO declared COVID-19 as a pandemic. On April 30, 2020; 3,239,220 confirmed cases were diagnosed across the globe with 228,860 deaths. The united states has the highest number of cases followed by spain and Italy. The first confirmed case of COVID-19 in Egypt was reported on 14 February 2020. As of April 30, 2020, there have been 5,537 confirmed cases, 1381 recovered and 392 deaths The overall global incidence of cancers in children aged 0-14 years is 140·6 per million, whereas, It's 130.9 per million in Egypt. Although cancer is a rare disease among children and adolescent, It's one of the leading causes of death. The prognosis of childhood cancer has significantly improved over the past decades with 5-year survival rates improved from 58% in the mid-1970 to around 83% in 2008-2014.
Little is known about the effects of COVID-19 on children with cancer. Children with cancer face numerous challenges during COVID-19 pandemic. Children with cancer are immunocompromised because of cancer or anti-cancer therapy. They have to be hospitalized to receive their anti-cancer therapy. The major problem we-as pediatric oncologist- face nowadays is how to organize pediatric cancer care in the COVID-19 ERA.
- Conditions
- Covid19
- Keywords
- Pediatric Oncology, COVID 19
- Medical subject headings
- COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
pediatric cancer care pattern during COVID 19 pandemic
Patterns of data will be mined to understand pediatric cancer care adaptation during COVID 19 pandemic
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2020
- Study start15 May 2020
- Primary completion1 Aug 2020
- Study completion1 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- 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
- Cross-sectional
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- South Egypt Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Motaz Elzembely, South Egypt Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04374838
- Sponsor's protocol ID
- COVID-19 and Pediatric Cancer
- Status last verified
- Aug 2020
- First submitted
- 1 May 2020
- Last updated
- 12 Aug 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhou P, Yang XL, Wang XG, Hu B, Zhang L, Zhang W, Si HR, Zhu Y, Li B, Huang CL, Chen HD, Chen J, Luo Y, Guo H, Jiang RD, Liu MQ, Chen Y, Shen XR, Wang X, Zheng XS, Zhao K, Chen QJ, Deng F, Liu LL, Yan B, Zhan FX, Wang YY, Xiao GF, Shi ZL. A pneumonia outbreak associated with a new coronavirus of probable bat origin. Nature. 2020 Mar;579(7798):270-273. doi: 10.1038/s41586-020-2012-7. Epub 2020 Feb 3.
PubMed 32015507Zhu N, Zhang D, Wang W, Li X, Yang B, Song J, Zhao X, Huang B, Shi W, Lu R, Niu P, Zhan F, Ma X, Wang D, Xu W, Wu G, Gao GF, Tan W; China Novel Coronavirus Investigating and Research Team. A Novel Coronavirus from Patients with Pneumonia in China, 2019. N Engl J Med. 2020 Feb 20;382(8):727-733. doi: 10.1056/NEJMoa2001017. Epub 2020 Jan 24.
PubMed 31978945Steliarova-Foucher E, Colombet M, Ries LAG, Moreno F, Dolya A, Bray F, Hesseling P, Shin HY, Stiller CA; IICC-3 contributors. International incidence of childhood cancer, 2001-10: a population-based registry study. Lancet Oncol. 2017 Jun;18(6):719-731. doi: 10.1016/S1470-2045(17)30186-9. Epub 2017 Apr 11.
PubMed 28410997
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of COVID-19 Pandemic on Pediatric Cancer Care
- ClinicalTrials.gov ID
- NCT04374838
- Acronym / sponsor ID
- COVID-19 and Pediatric Cancer
- Conditions
- Covid19
- Keywords
- Pediatric Oncology, COVID 19
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- South Egypt Cancer InstituteUniversity, hospital or other
- Study start
- 15 May 2020 (actual)
- Primary completion
- 1 Aug 2020 (actual)
- Study completion
- 1 Sep 2021 (estimated)
- First posted
- 5 May 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.
Observational cohort study to assess the effects of COVID19 on pediatric cancer care in Egypt and the Arab World through a survey applied to pediatric oncologists who will be interviewed either directly or through the internet to assess the effect of COVID 19 on pediatric cancer care
Detailed description
Corona viruses are single stranded enveloped RNA viruses with helical capsids. They infect wide variety of hosts including humans and animals. Coronavirus disease 2019 (COVID-19) was first described in December 2019 in Wuhan, the capital of China's Hubei province. A novel corona virus named severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) was identified as the causative organism. On 30 Jan 2020, WHO declared COVID-19 as a Public Health Emergency of International Concern (PHEIC). Subsequently on 11 March 2020, WHO declared COVID-19 as a pandemic. On April 30, 2020; 3,239,220 confirmed cases were diagnosed across the globe with 228,860 deaths. The united states has the highest number of cases followed by spain and Italy. The first confirmed case of COVID-19 in Egypt was reported on 14 February 2020. As of April 30, 2020, there have been 5,537 confirmed cases, 1381 recovered and 392 deaths The overall global incidence of cancers in children aged 0-14 years is 140·6 per million, whereas, It's 130.9 per million in Egypt. Although cancer is a rare disease among children and adolescent, It's one of the leading causes of death. The prognosis of childhood cancer has significantly improved over the past decades with 5-year survival rates improved from 58% in the mid-1970 to around 83% in 2008-2014.
Little is known about the effects of COVID-19 on children with cancer. Children with cancer face numerous challenges during COVID-19 pandemic. Children with cancer are immunocompromised because of cancer or anti-cancer therapy. They have to be hospitalized to receive their anti-cancer therapy. The major problem we-as pediatric oncologist- face nowadays is how to organize pediatric cancer care in the COVID-19 ERA.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Pediatric oncologists working in cancer centers in Egypt and the Arab world will be interviewed either directly or through the internet to assess the effect of COVID 19 on pediatric cancer care
Key inclusion criteria (1 listed)
- Pediatric oncologists working in cancer centers in Egypt and the Arab world during COVID 19 pandemic
Key exclusion criteria (1 listed)
- Pediatric oncologists not caring for patients during COVID 19 pandemic
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
pediatric cancer care pattern during COVID 19 pandemic
Time frame: 3 months
Patterns of data will be mined to understand pediatric cancer care adaptation during COVID 19 pandemic
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2020.
- Background: PubMed 32015507Zhou P, Yang XL, Wang XG, Hu B, Zhang L, Zhang W, Si HR, Zhu Y, Li B, Huang CL, Chen HD, Chen J, Luo Y, Guo H, Jiang RD, Liu MQ, Chen Y, Shen XR, Wang X, Zheng XS, Zhao K, Chen QJ, Deng F, Liu LL, Yan B, Zhan FX, Wang YY, Xiao GF, Shi ZL. A pneumonia outbreak associated with a new coronavirus of probable bat origin. Nature. 2020 Mar;579(7798):270-273. doi: 10.1038/s41586-020-2012-7. Epub 2020 Feb 3.
- Background: PubMed 31978945Zhu N, Zhang D, Wang W, Li X, Yang B, Song J, Zhao X, Huang B, Shi W, Lu R, Niu P, Zhan F, Ma X, Wang D, Xu W, Wu G, Gao GF, Tan W; China Novel Coronavirus Investigating and Research Team. A Novel Coronavirus from Patients with Pneumonia in China, 2019. N Engl J Med. 2020 Feb 20;382(8):727-733. doi: 10.1056/NEJMoa2001017. Epub 2020 Jan 24.
- Background: PubMed 28410997Steliarova-Foucher E, Colombet M, Ries LAG, Moreno F, Dolya A, Bray F, Hesseling P, Shin HY, Stiller CA; IICC-3 contributors. International incidence of childhood cancer, 2001-10: a population-based registry study. Lancet Oncol. 2017 Jun;18(6):719-731. doi: 10.1016/S1470-2045(17)30186-9. Epub 2017 Apr 11.
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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.
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 Covid19, run by South Egypt Cancer Institute at 1 site in Egypt.
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 1 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 12 Aug 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 Egypt. 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 Mahmoud M Elzembely, MD (00201146703107, elzimbily@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pediatric cancer care pattern during COVID 19 pandemic (time frame: 3 months). 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 NCT04374838, which also lists 3 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 12 Aug 2020.