NCT04449783

Brief Summary

trial to assess the effectiveness of pre-operative screening for COVID-19 in patients undergoing elective cancer surgery.

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
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 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

First Submitted

Initial submission to the registry

June 23, 2020

Completed
2 days until next milestone

Study Start

First participant enrolled

June 25, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 29, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 25, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 25, 2020

Completed
Last Updated

July 20, 2020

Status Verified

June 1, 2020

Enrollment Period

2 months

First QC Date

June 23, 2020

Last Update Submit

July 17, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • diagnosis of COVID before surgery

    Diagnosis of COVID on day of surgery (based on Clinical symptoms +/- positive swab diagnosis)

    prior to surgery

Secondary Outcomes (1)

  • diagnosis of COVID after surgery

    14 days post op

Study Arms (1)

study patients

Patients undergoing elective cancer surgery, who will receive pre-operative screening including reporting symptoms and nose and throat swabbing 48 hours prior to surgery

Other: pre-operative screeningOther: telephone consult

Interventions

reported symptoms plus nose and throat swabbing 48 hrs prior to surgery

study patients

telephone consult 14 days (+/- 2 days) to assess for any COVID-19 symptoms

study patients

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All adult patients undergoing elective cancer surgery with an inpatient stay

You may qualify if:

  • participants capable of giving informed consent,
  • gender: Male and Female
  • Age: 18 years and above
  • Preoperative cancer patients (elective)
  • Willing to be contacted by phone after hospital discharge
  • Patients listed for inpatient admission postoperatively (cancer patients)

You may not qualify if:

  • Cancer patients who require non-cancer surgery
  • emergency cancer operations
  • Patients under the age of 18
  • Patients who do not have capacity to consent
  • Cancer patients not requiring an inpatient stay postoperatively
  • Patients who it was not anticipated would require an inpatient stay preoperatively but required admission after surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Liverpool University Hospitals NHS Foundation Trust

Liverpool, Merseyside, L9 7AL, United Kingdom

RECRUITING

MeSH Terms

Conditions

COVID-19Neoplasms

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Robert Jones, MBChB

    Liverpool University Hospitals NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Peter Gaskell, MBChB

CONTACT

Study Design

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

Study Record Dates

First Submitted

June 23, 2020

First Posted

June 29, 2020

Study Start

June 25, 2020

Primary Completion

August 25, 2020

Study Completion

September 25, 2020

Last Updated

July 20, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

will not be shared

Locations