Patients with Carcinoma of Unknown Primary (CUP) have widespread cancer at diagnosis however the specific site of origin cannot be found, despite significant testing, making it difficult to treat. CUP has a poor prognosis; it is the 6th most common cause of cancer death in the UK. To date there have been limited studies investigating molecular genomics in CUP patients, resulting in limited evidence to evaluate whether genomic profiling has added value over and above the standard diagnostics provided in the NHS. As a result, our project will aim to; * Assess genomic sequencing (both in tissue and blood) for the diagnosis and treatment guidance in CUP patients including a comparison of the effectiveness of tissue and blood based biomarkers * Collect evidence to further develop technology that predicts an individual's response to a treatment * Develop innovative systems of clinical data capture in patients with CUP * Investigate novel biomarkers to determine the primary tumour location Approximately 120-140 CUP patients will be recruited across 7 UK NHS sites. Tumour samples will be collected from patients undergoing a standard of care procedure OR medically fit patients with accessible tumour. Archival tumour may also be obtained. Some samples will be stored for future translational research. Sequencing results alongside clinical data will be discussed by a multi-disciplinary CUP Molecular Tumour Board. They will provide oversight on the nature, clinical significance and relevance of the results. They will inform the local CUP team of any "actionable" genetic changes, which could potentially direct selection of a targeted therapy trial for that patient. Sequential blood samples will be collected to investigate genetic characteristics that may be able to predict response to therapy. The aggregated anonymised data will be made publicly available following completion of this trial.
Study Type
OBSERVATIONAL
Enrollment
117
UCL Cancer Institute
London, London, United Kingdom
Royal United Hospitals Bath NHS Foundation Trust
Bath, United Kingdom
Velindre Cancer Centre
Cardiff, United Kingdom
Edinburgh Cancer Centre
Edinburgh, United Kingdom
The Christie NHS Foundation Trust
Manchester, United Kingdom
Clatterbridge Cancer Centre NHS Foundation Trust
Metropolitan Borough of Wirral, United Kingdom
Torbay Hospital
Torquay, United Kingdom
To sequence tumour tissue and circulating tumour DNA from approximately 120- 140 patients with CUP in order to evaluate the activation state of various oncogenic pathways and improve treatment stratification approaches
Time frame: 18 months
To establish a genomic reporting mechanism whereby clinically relevant and potentially 'actionable' abnormalities found during sequencing/molecular characterisation can be reported to patients
Time frame: 18 months
To obtain archival tumour specimens, fresh tissue and sequential blood samples from approximately 120 - 140 patients with CUP
Time frame: 18 months
The comparative assessment of alternative assay methods (such as ctDNA) in parallel with whole genome sequencing in the diagnosis and treatment stratification for patients with CUP
Time frame: 18 months
To collect samples for future analysis for additional molecular characterisation techniques for detection of actionable aberrations. Examples include RNA sequencing, IHC, proteomics, methylation, analysis of immuno-biomarkers
Time frame: 18 months
To perform whole genome sequencing in patients where enough tumour tissue is available to explore novel predictive and resistance biomarkers
Time frame: 18 months
To build on close collaborations between the NHS CUP Hospitals, and external collaborators to progress basic/translational research models to investigate biomarkers to treatment in CUP and key biological drivers of this disease.
Time frame: 18 months
Collect evidence investigating the most effective way to stratify patients with CUP onto treatment.
Time frame: 18 months
To understand whether liquid biomarkers in CUP can be used to stratify patients and give prognostic information
Time frame: 18 months
Develop a data collection repository within the NHS for patients with CUP
Time frame: 18 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.