Cancer Clinical Trial
— CovidSurg-CanOfficial title:
Outcomes of Elective Cancer Surgery During the COVID-19 Pandemic Crisis: an International, Multicentre, Observational Cohort Study (CovidSurg-Cancer)
CovidSurg-Cancer is an international, multicentre, observational cohort study designed to
evaluate the 30-day COVID-19 infection rates in elective cancer surgery during the COVID-19
pandemic.
Centres can elect to include one or more cancer types in the study, in any combination,
depending on local expertise and capacity. During the pilot study, investigators should enrol
patients with confirmed diagnoses of:
- Colorectal cancer
- Oesophagogastric cancer
As a rapid response study to the COVID-19 pandemic, included cancer types will evolve
throughout the course of the CovidSurg-Cancer study period, for example, to include breast,
liver, pancreatic, gynaecological, urological cancers, or sarcomas.
Status | Recruiting |
Enrollment | 1000 |
Est. completion date | December 31, 2020 |
Est. primary completion date | December 31, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Centre Inclusion Criteria: - Any centre performing elective cancer surgery Inclusion Criteria (patient): - Adults (age =18 years) with a confirmed diagnosis of an included cancer type - Decision made for surgical management with a curative intent Exclusion Criteria: - Surgery planned with non-curative intent - Planned neoadjuvant therapy without a firm date for surgery, or awaiting restaging |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital del Henares | Madrid |
Lead Sponsor | Collaborator |
---|---|
University of Birmingham |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 30-day postoperative COVID-19 infection rate | Frequency of COVID-19 infection within 30 days | 30 days | |
Secondary | 30-day postoperative mortality rate | Number of deaths at 30-days post surgery | 30-days | |
Secondary | Postoperative critical care utilisation rate in high-risk cancer surgery patients. | Critical care utilisation in high-risk cancer surgery patients | 30-days | |
Secondary | Proportion of patients with delay of greater than 4 weeks from decision for surgery to date of surgery | Number of patients with a delay of more than 4 weeks from the decision taken for surgery to the date of surgery | More than 4 weeks from decision date | |
Secondary | Proportion of non-operated patients with progression to incurable disease by 3-months after decision for surgery | Number of non-operated patients with progression to incurable disease by 3-months after decision for surgery | Up to 3-months |
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