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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04581070
Recruitment Status : Terminated (Study stopped due to low accrual)
First Posted : October 9, 2020
Last Update Posted : October 30, 2020
Sponsor:
Information provided by (Responsible Party):
Cancer Trials Ireland

Study Description
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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.

Condition or disease
Cancer COVID-19

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.
Study Design
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Study Type : Observational
Actual Enrollment : 4 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: COVID-IYON Study. Prospective, Multisite, Descriptive, Observational Clinical/Epidemiological Study Examining Data Pertaining to Clinical Outcomes and Organizational Responses to the 2020 SARS-Coronavirus-2 (SARS-CoV-2) Pandemic
Actual Study Start Date : April 29, 2020
Actual Primary Completion Date : October 9, 2020
Actual Study Completion Date : October 9, 2020
Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. A qualitative description [ Time Frame: Up til 1 year ]
    A qualitative narrative description of national cancer care practises and risk mitigation strategies adopted in response to the SARS-CoV-2 pandemic.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients under the care of medical oncology & malignant haematology services, admitted at participating sites, who test positive for SARS-CoV-2 infection.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

There are no exclusion criteria

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04581070


Locations
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Ireland
Mater Misericordiae University Hospital
Dublin, Ireland
University Hospital Limerick
Limerick, Ireland
University Hospital Waterford
Waterford, Ireland
Sponsors and Collaborators
Cancer Trials Ireland
More Information
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Responsible Party: Cancer Trials Ireland
ClinicalTrials.gov Identifier: NCT04581070    
Other Study ID Numbers: CTRIAL-IE 20-01
First Posted: October 9, 2020    Key Record Dates
Last Update Posted: October 30, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No