McCarthy, Caroline http://orcid.org/0000-0003-3979-6643
Sacco, Joseph
Fedele, Stefano
Ho, Michael
Porter, Stephen
Liloglou, Triantafillos
Greenhalf, Bill
Robinson, Max
Young, Bridget
Cicconi, Silvia
Chauhan, Seema
Tesfaye, Binyam
Jackson, Richard
Sherratt, Frances
Shaw, Richard
Funding for this research was provided by:
Efficacy and Mechanism Evaluation Programme (14/209/13)
Article History
Received: 10 March 2021
Accepted: 15 June 2021
First Online: 5 July 2021
Declarations
:
: The trial protocol has been reviewed and approved by the North West Haydock Research Ethics Committee, reference number: 18/NW/0180. The trial has been registered with the MHRA; 04196/0048/001-0001.Vulnerable patients will not be recruited to the SAVER trial. Additional visits required by the trial are minimal, typically one extra visit for screening and randomisation and one extra trial review at 2 months. Additional tests will be required and include three blood tests over six months and one additional biopsy. WOCBP will not be recruited to the trial. The patient must: be fully informed, have received PIS (Patient Information Sheet) and considered this during a ‘cooling-off’ period and be competent to consent. The consent process is in two stages; the initial consent is simply for the screening biopsy and the second stage is consent for recruitment to the main study, if eligible. This includes consent for the collection and use of biological specimens in the mechanistic sub-study. Consent will be obtained by an appropriately qualified clinician. Patients being registered for the SAVER clinical trial should be informed by their clinical teams about the extra risks potentially associated with COVID-19, as they would before any cancer or pre-cancer treatment in the COVID-19 era.
: Not applicable
: The authors declare no competing interests.