Tumour Regulatory Molecules in Early Pancreatic Cancer Detection

Last updated: March 10, 2025
Sponsor: Hull University Teaching Hospitals NHS Trust
Overall Status: Active - Recruiting

Phase

N/A

Condition

Digestive System Neoplasms

Pancreatitis

Treatment

N/A

Clinical Study ID

NCT03536793
R2224
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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

Inclusion

Inclusion Criteria:

General

  • Capable of giving written informed consent

  • Age ≥18 years

Pancreatic Cancer Cohort

  • Diagnosed with localised pancreatic cancer amenable to resection (distalpancreatectomy, total pancreatectomy or Whipple's procedure).

OR - Diagnosed with inoperable localised pancreatic cancer and referred for further management (malignant control subgroup).

Pancreatic Cysts Cohort

  • Presence of cystic lesions where MDT have agreed further diagnostic interventionprocedures (including FNA/EUS) necessary.

OR - Patient the MDT have agreed have resectable lesions suspicious for pancreatic malignancy and going to surgery.

Benign Cohort

  • Referral for endoscopic cystogastrostomy for complicated acute pancreatitischaracterised by peripancreatic fluid collections and pseudocysts in development ormatured (non-resolving and requiring further intervention).

OR

  • Referral for cholecystectomy for cholocystitis/chololethiasis. OR

  • Patient planned to have endoscopy investigation for dyspepsia (normal controlsubgroup).

Exclusion

Exclusion Criteria:

General

  • 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

Study Design

Total Participants: 180
Study Start date:
October 24, 2018
Estimated Completion Date:
February 28, 2029

Connect with a study center

  • Castle Hill Hospital, Hull University Teaching Hospitals NHS Trust

    Cottingham, Kingston Upon Hull HU16 5JQ
    United Kingdom

    Active - Recruiting

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