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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

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.


Condition or disease Intervention/treatment
COVID-19 Coronavirus Cancer Surgery Procedure: Elective Cancer Surgery

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.

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: Outcomes of Elective Cancer Surgery During the COVID-19 Pandemic Crisis: an International, Multicentre, Observational Cohort Study (CovidSurg-Cancer)
Actual Study Start Date : March 30, 2020
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Group/Cohort Intervention/treatment
Cohort 1
Adult patients (aged ≥18 years), planned for curative cancer surgery, that have surgery completed during the COVID-19 pandemic
Procedure: Elective Cancer Surgery
Planned, curative 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
Procedure: Elective Cancer Surgery
Planned, curative cancer surgery




Primary Outcome Measures :
  1. 30-day postoperative COVID-19 infection rate [ Time Frame: 30 days ]
    Frequency of COVID-19 infection within 30 days


Secondary Outcome Measures :
  1. 30-day postoperative mortality rate [ Time Frame: 30-days ]
    Number of deaths at 30-days post surgery

  2. Postoperative critical care utilisation rate in high-risk cancer surgery patients. [ Time Frame: 30-days ]
    Critical care utilisation in high-risk cancer surgery patients

  3. 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

  4. 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



Information from the National Library of Medicine

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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 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
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

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): NCT04384926


Contacts
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Contact: Aneel Bhangu +44 1216272949 A.A.Bhangu@bham.ac.uk
Contact: Dmitri Nepogodiev +44 1216272949 D.Nepogodiev@bham.ac.uk

Locations
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Spain
Hospital del Henares Recruiting
Madrid, Spain
Contact: Ana Minaya-Bravo         
Principal Investigator: Ana Minaya-Bravo         
Sponsors and Collaborators
University of Birmingham
Investigators
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Principal Investigator: Aneel Bhangu University of Birmingham
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Birmingham
ClinicalTrials.gov Identifier: NCT04384926    
Other Study ID Numbers: CSC-20200324
First Posted: May 12, 2020    Key Record Dates
Last Update Posted: May 12, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No individual participant data will be made available to other researchers

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Birmingham:
Elective
Cancer Surgery
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases