Status:
UNKNOWN
Remote Monitoring of Cancer Patients With Suspected Covid-19
Lead Sponsor:
The Christie NHS Foundation Trust
Conditions:
COVID
Oncology
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
Since emerging in December 2019, coronavirus disease 2019 (Covid-19) has developed into an unprecedented global pandemic. The causative pathogen, the severe acute respiratory syndrome coronavirus 2 (S...
Detailed Description
This is a pilot, single arm, open label feasibility study. This is a single centre trial based in a large tertiary cancer centre which treats patients across all solid and haematological malignancies....
Eligibility Criteria
Inclusion
- Participants are capable of giving informed consent
- Male or female aged 18 or over
- Diagnosis of any solid tumour or haematological malignancy meeting one of the following criteria:
- Current malignant diagnosis
- Received anti-cancer treatment within the last two years
- Emergency presentation to hospital with symptoms consistent with Covid-19 deemed to meet the criteria for Covid-19 testing by admitting clinician.
- Deemed by the admitting clinician to be suitable for outpatient management of suspected Covid-19.
- Stable oxygen saturations of 95% or higher at time of emergency presentation.
- Able to complete tolerability questionnaire.
- Able and willing to comply with twice daily pulse oximetry monitoring as outlined in section 6 of the protocol.
- ECOG-PS \<4
- Life expectancy of greater than three months as assessed by screening investigator from review of electronic patient record.
Exclusion
- Patients hospitalized for more than 24 hours at initial presentation with symptoms consistent with Covid-19.
- Pregnant patients.
- Patients unable to give informed consent.
- Presence of ulceration or pre-existing skin rash at site of device application (left precordium and axillae). If only one axilla affected this is not an exclusion criterion if patient is happy to apply temperature sensor to the other axilla.
- Radiotherapy to the left chest wall either during or within the six months preceding the study. Plans for subsequent radiotherapy to commence after study completion are not an exclusion criterion. If only one axilla is within the planned radiotherapy field and patient is happy to apply temperature sensor to the other axilla this is not an exclusion criteria.
- History of allergy or contact dermatitis to medical adhesives e.g sticking plasters, ECG electrodes.
- Patients with pacemakers, implantable defibrillators or neurostimulators.
- Patients who are currently receiving treatment as part of a clinical study or have had their end of treatment visit for another clinical study less than 30 days prior to the study enrollment visit.
Key Trial Info
Start Date :
October 12 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2021
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04397705
Start Date
October 12 2020
End Date
April 1 2021
Last Update
February 11 2021
Active Locations (1)
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1
The Christie NHS Foundation Trust
Manchester, Greater Manchester, United Kingdom, M204BX