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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04384926
Other study ID # CSC-20200324
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 30, 2020
Est. completion date December 31, 2020

Study information

Verified date May 2020
Source University of Birmingham
Contact Aneel Bhangu
Phone +44 1216272949
Email A.A.Bhangu@bham.ac.uk
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Elective Cancer Surgery
Planned, curative cancer surgery

Locations

Country Name City State
Spain Hospital del Henares Madrid

Sponsors (1)

Lead Sponsor Collaborator
University of Birmingham

Country where clinical trial is conducted

Spain, 

Outcome

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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