TAY.CA.N The Tayside Cancer Network Initiative
Research type
Research Study
Full title
The Tayside Cancer Network (TAY.CA.N) Initiative: Utilisation of circulating tumour DNA (ctDNA) as a clinical biomarker for early detection of disease progression and recurrence in patients with pancreatic ductal adenocarcinoma (PDAC) and colorectal liver metastases (CRLM).
IRAS ID
343410
Contact name
Georgios Gemenetzis
Contact email
Sponsor organisation
University of Dundee
Duration of Study in the UK
2 years, 11 months, 30 days
Research summary
Pancreatic ductal adenocarcinoma (PDAC) and colorectal liver metastases cancer (CRLM) are diseases with poor prognosis. It is challenging to characterise how aggressive they are, which dictates response to treatment and patient prognosis. Serial follow-up imaging and existing blood biomarker tests. Existing monitoring has poor prognostic value and is insufficient in identifying high-risk patients for disease recurrence or progression. Cell-free genetic material circulating in the bloodstream, circulating tumour DNA (ctDNA), from these tumours has potential as a biomarker to improve early tumour detection and stratification of prognosis. By analysing the peripheral blood of patients, specific mutations related to these cancers can be identified and quantified to determine the burden of disease.
This proposal aims to characterise the feasibility of ctDNA as a clinical diagnostic test for monitoring of patients with PDAC and CRLM in order to stratify prognosis, assess treatment response, and identify increased incidence of disease recurrence.The first phase of the study aims to assess the assay’s feasibility and determine the framework for the longitudinal trial. Patients with a new diagnosis of PDAC (n=20) or CRLM (n=20) will undergo biopsy of the primary lesion during their planned clinical care procedure. This will be analysed via next generation sequencing along with a blood sample targeting the same mutations. Blood samples will also be taken from a group of healthy individuals (n=20) to confirm lack of mutated signals in their circulation.
The second phase is a longitudinal observational study of patients with a new PDAC (n=30) or CRLM (n=30) will have a biopsy as above and will undergo serial blood testing during their treatment: prior and during chemotherapy, prior and after surgery, and on 3-monthly during follow-up. All patients will be followed-up for up to 18 months or until death, disease recurrence, or withdrawal of consent.
REC name
East of Scotland Research Ethics Service REC 1
REC reference
25/ES/0022
Date of REC Opinion
8 May 2025
REC opinion
Further Information Favourable Opinion