Tumour Biomarkers in Cancer of Unknown Primary
Research type
Research Study
Full title
Incorporating genomic testing and tissue of origin predictions into the management of patients with Carcinoma Unknown Primary (CUP)
IRAS ID
348043
Contact name
Natalie Cook
Contact email
Sponsor organisation
University of Manchester
Duration of Study in the UK
2 years, 5 months, 8 days
Research summary
Cancer of Unknown Primary (CUP) is an under-researched area with significant unmet clinical need. They represent an heterogenous group of metastatic cancers, for which the primary site cannot be identified despite thorough clinical, radiological and histopathological work-up. Limited treatment options are available and prognosis is poor, typically in the region of a few months for the majority of patients.
One of the main factors limiting treatment options is the difficulty in identifying tissue of origin (TOO), meaning patients cannot be offered site-specific therapy. Ongoing research is looking at the role of DNA methylation analysis from a blood sample (liquid biopsy) as a means to identify TOO. This is of particular importance given tissue is notoriously difficult to obtain in CUP patients, and often the original biopsy sample has been exhausted by extensive diagnostic investigations. Additionally, new treatment options, such as immunotherapy, are not readily available in CUP due to licensing regulations and a lack of understanding around the immune-microenvironment, making it challenging to predict which patients might respond to immune-mediated therapy. Immunotherapy has revolutionised management in a subset of patients in other tumour sites but the role in CUP is less well established.
The hope is that with further investigation into the immune and genetic make up of CUP tumour tissue, we will be able to identify TOO and potential immune biomarkers which may predict response to novel therapies. Therefore, the aim of the study is to examine tissue from CUP tumours to identify potential immune biomarkers which may predict response to immune-mediated treatment and improve survival for some patients.
REC name
London - Brighton & Sussex Research Ethics Committee
REC reference
25/PR/0396
Date of REC Opinion
29 Apr 2025
REC opinion
Favourable Opinion