Tumour Regulatory Molecules in Early Pancreatic Cancer Detection
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHull University Teaching Hospitals NHS Trust
About this trial
The effective diagnosis of pancreatic cancer is often quite challenging, due to a lack of disease-specific symptoms, resulting in the majority of patients presenting with advanced disease, with an associated dismal prognosis. Earlier detection of pancreatic cancer, at a stage where surgery is feasible, would greatly increase the 5-year survival rate. Detecting pancreatic cancer early is therefore vital to improve the prognosis for these patients.
Pre-cancerous pancreatic cysts are an early indicator of malignant transformation. The ideal screening test would be capable of detecting pancreatic cancer at these initial stages. Current procedures for pancreatic cancer diagnosis are invasive, uncomfortable and costly, and can be considered unnecessary in those cysts found to be benign.
We propose to study a number of tumour regulatory molecules that have been the subject of research in laboratories at the University of Hull (e.g., tissue factor (TF), adrenomedullin (AM) using enzyme-linked immunosorbent assays (ELISA) tests) that have been studied in the context of carcinogenic transformation in more common malignancies but have yet to be fully tested in pancreatic malignant transformation. The recent introduction of platform technologies at the University of Hull has broadened this area of investigation by giving us access to next generation genomic sequencing and proteomic analyses of small amounts of tissue samples. We intend to analyse pancreatic cystic fluid samples using these technologies to discover new regulatory molecules.
Altogether, his study will measure the levels of novel regulatory molecules and genetic changes involved with pancreatic cancer carcinogenesis using a combination of conventional techniques (e.g. ELISA) and state-of-the-art platform technologies in pancreatic cysts from those patients in whom cancer may be suspected, to determine the potential of these molecules to serve as markers to detect early changes towards pancreatic cancer.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Capable of giving written informed consent
Age ≥18 years
Referral for cholecystectomy for cholocystitis/chololethiasis. OR
Patient planned to have endoscopy investigation for dyspepsia (normal control subgroup).
Disqualifiers
Inability to provide written informed consent
Other known malignant condition, either active or in complete remission ≤5 years
HIV, hepatitis C, or any other known communicable disease
Trial population
Patients will be recruited into 3 groups. A group of pancreatic cancer patients will be selected from those diagnosed with localised pancreatic cancer, including both those undergoing successful resection, and those undergoing biopsy only (localised, but radiologically inoperable) or where resection was attempted. A control group will be formed from age- and gender-matched patients receiving hepatobiliary surgery or endoscopic intervention (ERCP, PTCA, instrumentation of the biliary tree, endoscopic cystogastrostomy for pancreatic pseudocyst) for benign inflammatory conditions. A third group of patients will be derived from those with suspected pancreatic cancer who are undergoing follow-up for pancreatic cystic lesions. HUTH provides an EUS service that at this point investigates about 40 such cystic lesions annually with paracentesis and has a significant number of cystic lesions under close follow-up.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
180 Participants
are grouped into 3 trial groupsGroup A: Pancreatic cysts
Group B: Pancreatic cancers
Group C: Benign hepatopancreatobiliary conditions
Trial outcomes
Primary outcomes
1
Measurement of the accuracy of protein markers (e.g., TF, AM) in detecting early stage pancreatic cancer by comparison of laboratory results from ELISA assays and platform technologies to patient clinical data.
The ELISAs and platform technologies will provide measurements of the markers (e.g. TF, AM) concentrations in patient urine, serum and cystic fluid samples. This will then be immediately linked to information on the pancreatic cancer diagnosis where it is known (i.e. cancer and control groups) and, for patients with pancreatic cysts, linked to information obtained following diagnostic work-up (and over the follow-up period), to determine the accuracy of these markers in the potential early detection of pancreatic cancer within the Hull University Teaching Hospitals NHS Trust (HUTH) pancreatic cancer population. Patients with a known cancer diagnosis, compared to controls, will be used to determine whether a suitable cut-off for each assay can be found for accurate detection.
Time frame
During the recruitment phase.Sponsors and contacts
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Hull University Teaching Hospitals NHS Trust
Lead sponsor
University of Hull
Collaborator
Source ClinicalTrials.gov