A multi-centre CTIMP (Clinical Trial of an Investigational Medicinal Product) aiming to optimise the dose, and then evaluate, oral 5-ALA administration for intra-operative fluorescence diagnosis of metastatic lymph nodes in colon cancer. Trial idea and subsequent grant application developed by two surgeons in Leeds and Dublin with expertise in laparoscopic surgery and lymph node mapping.
Countries: United Kingdom and Republic of Ireland
The University of Leeds acted as sponsor for the trial, with co-ordination of the trial delegated between a clinical research fellow and the Clinical Trials Research Unit at the University of Leeds.
The University of Leeds obtained funding for the trial as the host organisation. This included payments to facilitate delivery of the research at both sites in the UK and Ireland.
TThe University of Leeds contracted with each participating research site, the pharmaceutical trial providing the IMP (investigational medicinal product) and a cancer research organisation in Ireland.
The University of Leeds put in place clinical trials insurance cover for the duration of the trial. The Irish site was responsible for ensuring appropriate insurance or indemnity for clinical negligence was in place in relation to their clinical activities related to the trial.
Use of a cancer research trial organisation to complete and obtain the required regulatory and ethical approvals in Ireland. The Clinical Trials Research Unit at the University of Leeds was responsible for the expedited reporting of all SUSARS, serious breaches and urgent safety measures to the competent authorities in the UK and the Republic of Ireland.
One single protocol was used for both UK and international sites. Pragmatic trial design, operative specifics were at the discretion of the operating surgeon.
Sites monitoring, including a visit to pharmacy, took place after two patients had been recruited at each site. Subsequent visits were determined by the recruitment rate, with the possibility of triggered site visits based on central monitoring findings. All Irish consent forms were monitored at site rather than sent to Leeds to central monitoring.
Distribution of Trial Supplies
A trial specific supply of the trial IMP, 5-ALA, was secured by the University of Leeds. This was distributed directly to each site from the manufacturer.
All data for the trial was captured on paper Case Report Forms (CRF) and were sent to the clinical research fellow for entry onto the trial database.
To enable a central pathological review, sites were required to send glass tissue slides, lymph node and tissue blocks. Patients were invited to provide consent to obtain redundant tumour samples for future research an optional component of the trial. The trial budget covered shipping of tissue from sites to Leeds.
There were no PROMS or health economic outcomes included due to the stage of the trial.
Data Ownership & Publication
All trial data was owned by the University of Leeds as host institution. Sites were not permitted to publish concerning their patients which was directly relevant to the questions posed in the trial until the first publication of the primary endpoint analysis. Both surgeons were named as authors in publications due to their input into the trial design and the small size of the trial.