Aims: Cancer of unknown primary (CUP) describes a heterogenous collection of metastatic malignancies without an identifiable primary site despite standardised clinical investigation. Evidence to guide diagnosis, molecular therapeutics and treatment, and supportive care for CUP patients is lacking. SUPER is a national prospective cohort study initiated to address these information gaps by (1) describing the clinical, quality of life, and psychosocial characteristics of a CUP cohort, and (2) establishing a biobank/ databank resource of CUP.
Methods: CUP patients were recruited to SUPER from 12 participating sites across Australia (2013 - 2021) over three phases. Project management was co-ordinated between Peter MacCallum Cancer Centre and the University of Melbourne and testing was also done by two independent labs at these centres. Clinical and patient reported outcome data was collected over 12 months. Patient samples underwent mutational profiling and tissue-of-origin prediction by molecular profiling. Results were discussed in a molecular tumour board (MTB). Clinical management questionnaires were completed before and after receiving molecular results.
Results: 449 patients were recruited over three study phases. Molecular tests were successfully completed in 72%, 68% and 85% of patients in phase 1, 2 and 3, respectively. Incremental improvements to the study structure included;
1) Electronic data capture during study recruitment.
2) Remote consents were necessitated by the COVID-19 pandemic.
3) Project management software to assist with sample tracking and data sharing.
4) Centralised pathology review was introduced.
5) More advanced molecular profiling introduced - whole genome and transcriptome sequencing.
6) MTB discussion summarised by a clinical fellow to capture detailed case discussions.
Conclusions: Over three phases, data collection and management became digitised enabling greater flexibility and streamlined tracking of samples. The testing success rate increased, and more comprehensive molecular profiling was done. More information was returned to treating clinicians with a reduced turn-around-time.