NCT04384926

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 30, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 11, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 12, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

May 12, 2020

Status Verified

May 1, 2020

Enrollment Period

9 months

First QC Date

May 11, 2020

Last Update Submit

May 11, 2020

Conditions

Keywords

ElectiveCancer Surgery

Outcome Measures

Primary Outcomes (1)

  • 30-day postoperative COVID-19 infection rate

    Frequency of COVID-19 infection within 30 days

    30 days

Secondary Outcomes (4)

  • 30-day postoperative mortality rate

    30-days

  • Postoperative critical care utilisation rate in high-risk cancer surgery patients.

    30-days

  • Proportion of patients with delay of greater than 4 weeks from decision for surgery to date of surgery

    More than 4 weeks from decision date

  • Proportion of non-operated patients with progression to incurable disease by 3-months after decision for surgery

    Up to 3-months

Study Arms (2)

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

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

Interventions

Planned, curative cancer surgery

Cohort 1Cohort 2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • \- Any centre performing elective cancer surgery
  • Adults (age ≥18 years) with a confirmed diagnosis of an included cancer type
  • Decision made for surgical management with a curative intent

You may not qualify if:

  • Surgery planned with non-curative intent
  • Planned neoadjuvant therapy without a firm date for surgery, or awaiting restaging

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital del Henares

Madrid, Spain

RECRUITING

Related Publications (3)

  • NIHR Global Health Research Unit on Global Surgery; STARSurg Collaborative. A prognostic model for use before elective surgery to estimate the risk of postoperative pulmonary complications (GSU-Pulmonary Score): a development and validation study in three international cohorts. Lancet Digit Health. 2024 Jul;6(7):e507-e519. doi: 10.1016/S2589-7500(24)00065-7.

  • COVIDSurg Collaborative. Effect of COVID-19 pandemic lockdowns on planned cancer surgery for 15 tumour types in 61 countries: an international, prospective, cohort study. Lancet Oncol. 2021 Nov;22(11):1507-1517. doi: 10.1016/S1470-2045(21)00493-9. Epub 2021 Oct 5.

  • Glasbey JC, Nepogodiev D, Simoes JFF, Omar O, Li E, Venn ML, Pgdme, Abou Chaar MK, Capizzi V, Chaudhry D, Desai A, Edwards JG, Evans JP, Fiore M, Videria JF, Ford SJ, Ganly I, Griffiths EA, Gujjuri RR, Kolias AG, Kaafarani HMA, Minaya-Bravo A, McKay SC, Mohan HM, Roberts KJ, San Miguel-Mendez C, Pockney P, Shaw R, Smart NJ, Stewart GD, Sundar Mrcog S, Vidya R, Bhangu AA; COVIDSurg Collaborative. Elective Cancer Surgery in COVID-19-Free Surgical Pathways During the SARS-CoV-2 Pandemic: An International, Multicenter, Comparative Cohort Study. J Clin Oncol. 2021 Jan 1;39(1):66-78. doi: 10.1200/JCO.20.01933. Epub 2020 Oct 6.

MeSH Terms

Conditions

COVID-19Coronavirus InfectionsNeoplasms

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Aneel Bhangu

    University of Birmingham

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 11, 2020

First Posted

May 12, 2020

Study Start

March 30, 2020

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

May 12, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

No individual participant data will be made available to other researchers

Locations