The COVID-IYON Study - Study Examining Data Pertaining to... | NCT04581070

Studies
The COVID-IYON Study - Study Examining Data Pertaining to Clinical Outcomes and Organisational Responses to the 2020 SARS-CoV-2 Pandemic"

NCT04581070

Sponsor

Cancer Trials Ireland

Status

Terminated

Last Update Posted

Oct 30, 2020Actual

Enrollment

4Actual

Phase

Not provided

Conditions

Cancer
COVID-19

Interventions

Not provided

Countries

Ireland

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

Oct 2020

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Study stopped due to low accrual

Expanded Access Info

Start Date

Apr 29, 2020Actual

Primary Completion Date

Oct 9, 2020Actual

Completion Date

Oct 9, 2020Actual

First Submitted Date

May 29, 2020

First Submission Date that Met QC Criteria

Oct 8, 2020

First Posted Date

Oct 9, 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

Oct 28, 2020

Last Update Posted Date

Oct 30, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

This is a prospective, multisite, descriptive, observational clinical/epidemiological study examining both quantitative and qualitative data pertaining to clinical outcomes and organizational responses to the 2020 SARS-Coronavirus-2 (SARS-CoV-2) pandemic.

Detailed Description

This study collects real-time observational data regarding the impact of SARS-CoV-2 infection on patients with cancer, and on the functioning and organisation of cancer and malignant haematology services in the Republic of Ireland in response to the 2020 SARS-CoV-2 pandemic.

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

4Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
A qualitative description	A qualitative narrative description of national cancer care practises and risk mitigation strategies adopted in response to the SARS-CoV-2 pandemic.	Up til 1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age ≥ 18
Informed consent has been obtained.
Cytotoxic chemotherapy, targeted anticancer therapy, immunomodulatory anticancer therapy, hormonotherapy, radiotherapy, oncologic surgery, or other anticancer treatment within the last 12 months (ongoing and completed).
Tested positive for SARS-CoV-2.

Exclusion Criteria:

There are no exclusion criteria

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients under the care of medical oncology & malignant haematology services, admitted at participating sites, who test positive for SARS-CoV-2 infection.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mater Misericordiae University Hospital		Dublin			Ireland
University Hospital Limerick

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009369	Neoplasms
D000086382	COVID-19

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided