Tumour Regulatory Molecules in Early Pancreatic Cancer Detection

NCT ID: NCT03536793

Last Updated: 2025-03-11

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 180 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-10-24
• Study Completion Date: 2029-02-28

Brief 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.

Conditions

Cancer of Pancreas; Pancreas Cyst

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Pancreatic cysts

Samples (urine, serum, whole blood and cystic fluid) will be taken from 50 patients with pancreatic cysts on follow-up. These will be sent to the University of Hull for analysis of tumour regulatory molecules (e.g. TF, AM). Some of the cystic fluid and the whole blood sample will either be analysed at the University of Hull or a commercial laboratory for proteomic and genomic data. Collection will occur on the same day of the participants' routinely indicated procedure.

No interventions assigned to this group

Pancreatic cancers

Samples (urine and serum) will be taken from 50 patients diagnosed with pancreatic cancer (resectable and non-resectable). These will be sent to the University of Hull for analysis of tumour regulatory molecules (e.g. TF, AM).

No interventions assigned to this group

Benign hepatopancreatobiliary conditions

Samples (urine and serum) will be taken from 80 age- and gender-matched control patients - 20 patients with acute pancreatitis and a non-resolving pseudocyst, 20 undergoing cholecystectomy for stones, 20 undergoing cholecystectomy for inflammation and 20 patients undergoing investigations for dyspepsia (normal control subgroup). These will be sent to the University of Hull for analysis of tumour regulatory molecules (e.g. TF, AM).

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

General

• Capable of giving written informed consent
• Age ≥18 years

Pancreatic Cancer Cohort

• Diagnosed with localised pancreatic cancer amenable to resection (distal pancreatectomy, 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 intervention procedures (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 pancreatitis characterised by peripancreatic fluid collections and pseudocysts in development or matured (non-resolving and requiring further intervention).

OR

• Referral for cholecystectomy for cholocystitis/chololethiasis. OR
• Patient planned to have endoscopy investigation for dyspepsia (normal control subgroup).

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Hull

OTHER

Sponsor Role: collaborator

Hull University Teaching Hospitals NHS Trust

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anthony Maraveyas

Role: PRINCIPAL_INVESTIGATOR

Hull University Teaching Hospitals NHS Trust

Locations

Castle Hill Hospital, Hull University Teaching Hospitals NHS Trust

Cottingham, Kingston Upon Hull, United Kingdom

Site Status: RECRUITING

Countries

United Kingdom

Central Contacts

Anthony Maraveyas

Role: CONTACT

anthony.maraveyas@nhs.net

01482 461245

James Illingworth

Role: CONTACT

james.illingworth3@nhs.net

01482 461903

Facility Contacts

Anthony Maraveyas

Role: primary

anthony.maraveyas@nhs.net

01482 461245

Other Identifiers

R2224

Identifier Type: -

Identifier Source: org_study_id