Covid19CHICANENCT04449783
Preoperative Shielding and N/T RT-PCR Swabbing for Elective Cancer Surgery
An observational study of Covid19 and Cancer, run by Liverpool University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
trial to assess the effectiveness of pre-operative screening for COVID-19 in patients undergoing elective cancer surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- pre-operative screening and telephone consult
- How many people
- 150 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 25 Jun 2020to 25 Sep 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: All adult patients undergoing elective cancer surgery with an inpatient stay
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Liverpool University Hospitals NHS Foundation Trust
Liverpool, Merseyside, L9 7AL
Robert Jones, MBChB, 0151 525 5980, robert.jones@liverpool.ac.uk
Robert Jones, MBChB
About this study
Official title: A Cohort Study to Assess the Effectiveness of Preoperative Shielding and N/T RT-PCR Swabbing for Elective Cancer Surgery Patients in the COVID-19 Pandemic
trial to assess the effectiveness of pre-operative screening for COVID-19 in patients undergoing elective cancer surgery.
Read the detailed description
- Background: The optimal method of screening patients for COVID infection before elective cancer surgery is unclear. Provisional data from the international COVIDsurg audit as well as a similar study from China has shown mortality rates of in excess of 20% for COVID +ve patients undergoing surgery and so ensuring patients do not have infection before surgery is critical (1). Current practice for the preoperative screening of elective surgical patients involves a period of self-isolation, assessment of self-reported symptoms and nose and throat swab testing. Many patients are asymptomatic with COVID and the false negative rate of RT-PCR nose and throat swabs may be as high as 30% (2,3). Furthermore, we do not know how effective our strategy is at preventing hospital acquired COVID in the days after surgery. Patients are currently going to designated clean (silver) wards postoperatively to reduce this risk with other patient who have tested negatively to the above screening process too
- Rationale:
The aim of this study is to assess the rate of perioperative COVID in elective surgical patients, and to assess whether RT-PCR swabbing adds any additional value i.e. does it detect clinically important asymptomatic patients.
If asymptomatic patients are diagnosed preoperatively this will reduce perioperative morbidity and mortality as well as confirming this as an appropriate preoperative screening process. Alternatively, should nose and throat swabbing not improve the diagnosis of COVID-19 in asymptomatic patients this trial may stop unnecessary visit to the hospital where they may be more likely to contract COVID-19 and reduce the use of a limited resource.
- Being tested
- pre-operative screening, telephone consult
- Medical subject headings
- COVID-19, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pre-operative screeningOther
reported symptoms plus nose and throat swabbing 48 hrs prior to surgery
telephone consultOther
telephone consult 14 days (+/- 2 days) to assess for any COVID-19 symptoms
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: pre-operative screening; Other: telephone consult |
What is being measured
The primary outcome is the main question the study is designed to answer.
diagnosis of COVID before surgery
Diagnosis of COVID on day of surgery (based on Clinical symptoms +/- positive swab diagnosis)
Measured: prior to surgery
Secondary outcomes (1)
diagnosis of COVID after surgery
Diagnosis by day 14 (+/-2) post-surgery (based on Clinical symptoms from inpatient notes or telephone consultation +/- positive swab diagnosis)
Measured: 14 days post op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2020
- Study start25 Jun 2020
- Primary completion25 Aug 2020 (estimated)
- Study completion25 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Liverpool University Hospitals NHS Foundation Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Robert Jones, MBChB, Principal investigator, Liverpool University Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04449783
- Sponsor's protocol ID
- SP0355
- Acronym
- CHICANE
- Status last verified
- Jun 2020
- First submitted
- 23 Jun 2020
- Last updated
- 20 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: will not be shared
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cohort Study to Assess the Effectiveness of Preoperative Shielding and N/T RT-PCR Swabbing for Elective Cancer Surgery Patients in the COVID-19 Pandemic
- ClinicalTrials.gov ID
- NCT04449783
- Acronym / sponsor ID
- CHICANE / SP0355
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Liverpool University Hospitals NHS Foundation TrustOther government
- Study start
- 25 Jun 2020 (actual)
- Primary completion
- 25 Aug 2020 (estimated)
- Study completion
- 25 Sep 2020 (estimated)
- First posted
- 29 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
trial to assess the effectiveness of pre-operative screening for COVID-19 in patients undergoing elective cancer surgery.
Detailed description
- Background: The optimal method of screening patients for COVID infection before elective cancer surgery is unclear. Provisional data from the international COVIDsurg audit as well as a similar study from China has shown mortality rates of in excess of 20% for COVID +ve patients undergoing surgery and so ensuring patients do not have infection before surgery is critical (1). Current practice for the preoperative screening of elective surgical patients involves a period of self-isolation, assessment of self-reported symptoms and nose and throat swab testing. Many patients are asymptomatic with COVID and the false negative rate of RT-PCR nose and throat swabs may be as high as 30% (2,3). Furthermore, we do not know how effective our strategy is at preventing hospital acquired COVID in the days after surgery. Patients are currently going to designated clean (silver) wards postoperatively to reduce this risk with other patient who have tested negatively to the above screening process too
- Rationale:
The aim of this study is to assess the rate of perioperative COVID in elective surgical patients, and to assess whether RT-PCR swabbing adds any additional value i.e. does it detect clinically important asymptomatic patients.
If asymptomatic patients are diagnosed preoperatively this will reduce perioperative morbidity and mortality as well as confirming this as an appropriate preoperative screening process. Alternatively, should nose and throat swabbing not improve the diagnosis of COVID-19 in asymptomatic patients this trial may stop unnecessary visit to the hospital where they may be more likely to contract COVID-19 and reduce the use of a limited resource.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| study patients | – | Other: pre-operative screening, Other: telephone consultPatients undergoing elective cancer surgery, who will receive pre-operative screening including reporting symptoms and nose and throat swabbing 48 hours prior to surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All adult patients undergoing elective cancer surgery with an inpatient stay
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pre-operative screeningreported symptoms plus nose and throat swabbing 48 hrs prior to surgery | Other | study patients |
| telephone consulttelephone consult 14 days (+/- 2 days) to assess for any COVID-19 symptoms | Other | study patients |
Primary outcome
diagnosis of COVID before surgery
Time frame: prior to surgery
Diagnosis of COVID on day of surgery (based on Clinical symptoms +/- positive swab diagnosis)
1 secondary outcome
diagnosis of COVID after surgery
Time frame: 14 days post op
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2020.
- Individual participant dataSharing planned: No. will not be shared
Related trials for Covid19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Jones, MBChB principal investigator
Liverpool University Hospitals NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19 and Cancer, run by Liverpool University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Robert Jones, MBChB (0151 525 5980, robert.jones@liverpool.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
diagnosis of COVID before surgery (time frame: prior to surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2020.