Tumour Regulatory Molecules in Early Pancreatic Cancer Detection (TEM-PAC)

February 19, 2024 updated by: Hull University Teaching Hospitals NHS Trust

Study of Tumour Regulatory Molecules as Markers of Malignancy in Pancreatic Cystic Lesions

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

180

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United Kingdom
    • Kingston Upon Hull
      • Cottingham, Kingston Upon Hull, United Kingdom, HU16 5JQ
        • Recruiting
        • Castle Hill Hospital, Hull University Teaching Hospitals NHS Trust
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study 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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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.
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).
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: During the recruitment phase.

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.
During the recruitment phase.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hull University Teaching Hospitals NHS Trust

Collaborators

University of Hull

Investigators

  • Principal Investigator: Anthony Maraveyas, Hull University Teaching Hospitals NHS Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 24, 2018

Primary Completion (Estimated)

February 28, 2026

Study Completion (Estimated)

February 28, 2029

Study Registration Dates

First Submitted

April 25, 2018

First Submitted That Met QC Criteria

May 23, 2018

First Posted (Actual)

May 25, 2018

Study Record Updates

Last Update Posted (Estimated)

February 21, 2024

Last Update Submitted That Met QC Criteria

February 19, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R2224

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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