- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04581070
The COVID-IYON Study - Study Examining Data Pertaining to Clinical Outcomes and Organisational Responses to the 2020 SARS-CoV-2 Pandemic"
October 28, 2020 updated by: Cancer Trials Ireland
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
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.
Study Overview
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 Type
Observational
Enrollment (Actual)
4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Dublin, Ireland
- Mater Misericordiae University Hospital
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Limerick, Ireland
- University Hospital Limerick
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Waterford, Ireland
- University Hospital Waterford
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Up til 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 29, 2020
Primary Completion (Actual)
October 9, 2020
Study Completion (Actual)
October 9, 2020
Study Registration Dates
First Submitted
May 29, 2020
First Submitted That Met QC Criteria
October 8, 2020
First Posted (Actual)
October 9, 2020
Study Record Updates
Last Update Posted (Actual)
October 30, 2020
Last Update Submitted That Met QC Criteria
October 28, 2020
Last Verified
October 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- CTRIAL-IE 20-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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