Effect of COVID-19 Pandemic on Pediatric Cancer Care | NCT04374838

Studies
Effect of COVID-19 Pandemic on Pediatric Cancer Care

NCT04374838

Sponsor

South Egypt Cancer Institute

Status

Unknown status

Last Update Posted

Aug 12, 2020Actual

Enrollment

20Estimated

Phase

Not provided

Conditions

Covid19

Interventions

Not provided

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 15, 2020Actual

Primary Completion Date

Aug 1, 2020Actual

Completion Date

Sep 1, 2021Estimated

First Submitted Date

May 1, 2020

First Submission Date that Met QC Criteria

May 1, 2020

First Posted Date

May 5, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 10, 2020

Last Update Posted Date

Aug 12, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mahmoud Motaz Elzembely, Lecturer of Pediatric Oncology, South Egypt Cancer InstitutePrincipal Investigator

Lead Sponsor

South Egypt Cancer InstituteOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
pediatric cancer care pattern during COVID 19 pandemic	Patterns of data will be mined to understand pediatric cancer care adaptation during COVID 19 pandemic	3 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Pediatric oncologists working in cancer centers in Egypt and the Arab world during COVID 19 pandemic

Exclusion Criteria:

Pediatric oncologists not caring for patients during COVID 19 pandemic

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder 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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mahmoud M Elzembely, MD	Contact	00201146703107		elzimbily@aun.edu.eg

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
South Egypt Cancer Institute, Assiut University	Recruiting	Asyut		71515	Egypt

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32015507	Background	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.
31978945

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections