Biomarker analysis in pancreatic cancer
Research type
Research Study
Full title
Biomarker analysis for the early detection of pancreatic cancer using serial samples in a nested case-control study.
IRAS ID
206647
Contact name
Usha Menon
Contact email
Sponsor organisation
University College London
Clinicaltrials.gov Identifier
UCL Data Protection Registration Number, Z6364106/06/78
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
Pancreatic cancer is the only cancer with a predicted worsening mortality trend in Europe. Despite decades of research into new drug treatments the best option still remains to be surgery. However, surgery is possible only for cases with smaller, operable lesions at diagnosis and those that have not spread beyond the pancreas. Unfortunately pancreatic cancer typically develops with few recognisable symptoms and only 10–20% of patients are diagnosed at a stage amenable to resection and possible cure. Thus diagnosis often comes at a late stage with only 8.7% of pancreatic cancers being diagnosed early when the disease is still localised and operable.
There are currently no screening methods in the general population for the early detection of pancreatic cancer. Carbohydrate antigen sialyl Lewis A (CA19-9) is an O-linked glycoprotein that is expressed on the surface of a number of gastrointestinal cancer cells. CA19-9 has been extensively studied in pancreatic cancer and is the only blood-based biomarker that is routinely used in the management of patients diagnosed with pancreatic cancer and as a diagnostic aid. Approximately 5-10% of the population have point mutations in the Lewis gene (FUT3) which causes CA19-9 not to be produced, even in the presence of large tumours, due to inactivation of the 1-3/4-L-fucosyl transferase enzyme.
The aim of this project is to analyse the CA19-9 biomarker and Lewis antigen status using the longitudinal pre-diagnosis serum samples from pancreatic cancer cases already collected during the United Kingdom Collaborative Trial of Ovarian Cancer Screening (UKCTOCS) trial. Control (non-cancer) samples as well as benign pancreatic conditions (pancreatitis and pancreatic cysts) would be used for comparison. Analysis of the longitudinal biomarker changes over time (rather than a single CA19-9 cut-off measurement) that might indicate the presence of cancer year(s) before clinical diagnosis could have considerable clinical benefit for the patients.
REC name
East of England - Cambridge South Research Ethics Committee
REC reference
16/EE/0303
Date of REC Opinion
12 Jul 2016
REC opinion
Favourable Opinion