Clinical trial NCT04384926: 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)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19
Coronavirus
Cancer
Surgery
Keywords: Elective
Cancer Surgery
Lead sponsor: University of Birmingham
Sponsor class: OTHER
First posted: 2020-05-12
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
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

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.

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

Primary outcomes:
measure: 30-day postoperative COVID-19 infection rate
timeFrame: 30 days
Secondary outcomes:
measure: 30-day postoperative mortality rate
timeFrame: 30-days
measure: Postoperative critical care utilisation rate in high-risk cancer surgery patients.
timeFrame: 30-days
measure: Proportion of patients with delay of greater than 4 weeks from decision for surgery to date of surgery
timeFrame: More than 4 weeks from decision date
measure: Proportion of non-operated patients with progression to incurable disease by 3-months after decision for surgery
timeFrame: Up to 3-months
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital del Henares
Study officials:
affiliation: University of Birmingham
name: Aneel Bhangu
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.