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Outcomes of Elective Cancer Surgery During the COVID-19 Pandemic Crisis (CovidSurg-Can)

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ClinicalTrials.gov Identifier: NCT04384926
Recruitment Status : Recruiting
First Posted : May 12, 2020
Last Update Posted : May 12, 2020
Sponsor:
Information provided by (Responsible Party):
University of Birmingham

Tracking Information
First Submitted Date May 11, 2020
First Posted Date May 12, 2020
Last Update Posted Date May 12, 2020
Actual Study Start Date March 30, 2020
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 11, 2020)
30-day postoperative COVID-19 infection rate [ Time Frame: 30 days ]
Frequency of COVID-19 infection within 30 days
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: May 11, 2020)
  • 30-day postoperative mortality rate [ Time Frame: 30-days ]
    Number of deaths at 30-days post surgery
  • Postoperative critical care utilisation rate in high-risk cancer surgery patients. [ Time Frame: 30-days ]
    Critical care utilisation in high-risk cancer surgery patients
  • Proportion of patients with delay of greater than 4 weeks from decision for surgery to date of surgery [ Time Frame: More than 4 weeks from decision date ]
    Number of patients with a delay of more than 4 weeks from the decision taken for surgery to the date of surgery
  • Proportion of non-operated patients with progression to incurable disease by 3-months after decision for surgery [ Time Frame: Up to 3-months ]
    Number of non-operated patients with progression to incurable disease by 3-months after decision for surgery
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Outcomes of Elective Cancer Surgery During the COVID-19 Pandemic Crisis
Official Title Outcomes of Elective Cancer Surgery During the COVID-19 Pandemic Crisis: an International, Multicentre, Observational Cohort Study (CovidSurg-Cancer)
Brief Summary

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.

Detailed Description

The rapid emergence of the COVID-19 virus has led to a global impact on elective surgical care.

We have very little evidence to guide us. The magnitude and effects of these changes are uncertain. The safety of operating on patients electively with the risks of COVID-19 postoperative pneumonia is unknown.

High-quality data will allow policy planning at regional and hospital level for both this outbreak and future pandemics. CovidSurg-Cancer will run in parallel to CovidSurg (which is capturing outcomes of patients undergoing surgery for all indications with concurrent COVID-19).

The primary aim is to evaluate the 30-day COVID-19 infection rates in elective cancer surgery during the COVID-19 pandemic.

Secondary aims include; comparison of the 30-day postoperative mortality rate in cancer surgery patients that develop COVID-19 infection versus those who do not; an exploration of the scale of resource constraints related to the COVID-19 pandemic, and their impact on outcomes of elective cancer surgery; to explore variation in the selection of patients for continuing elective cancer surgery during the COVID-19 pandemic; to evaluate the impact of the COVID-19 pandemic on treatment pathways for cancers with a decision for surgical resection with curative intent.

This investigator-led, non-commercial, non-interventional study is extremely low to zero risk. This study does not collect any patient identifiable information and data will not be analysed at hospital-level.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population
  • Patients planned for curative cancer surgery that have surgery completed during the COVID-19 pandemic
  • Patients planned for curative cancer surgery that have surgery delayed or cancelled during the COVID-19 pandemic
Condition
  • COVID-19
  • Coronavirus
  • Cancer
  • Surgery
Intervention Procedure: Elective Cancer Surgery
Planned, curative cancer surgery
Study Groups/Cohorts
  • Cohort 1
    Adult patients (aged ≥18 years), planned for curative cancer surgery, that have surgery completed during the COVID-19 pandemic
    Intervention: Procedure: Elective Cancer Surgery
  • Cohort 2
    Adult patients (aged ≥18 years), planned for curative cancer surgery, that have surgery delayed or cancelled during the COVID-19 pandemic
    Intervention: Procedure: Elective Cancer Surgery
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: May 11, 2020)
1000
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2020
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Aneel Bhangu +44 1216272949 A.A.Bhangu@bham.ac.uk
Contact: Dmitri Nepogodiev +44 1216272949 D.Nepogodiev@bham.ac.uk
Listed Location Countries Spain
Removed Location Countries  
 
Administrative Information
NCT Number NCT04384926
Other Study ID Numbers CSC-20200324
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Plan Description: No individual participant data will be made available to other researchers
Responsible Party University of Birmingham
Study Sponsor University of Birmingham
Collaborators Not Provided
Investigators
Principal Investigator: Aneel Bhangu University of Birmingham
PRS Account University of Birmingham
Verification Date May 2020