Cancer of PancreasTEM-PACNCT03536793
Tumour Regulatory Molecules in Early Pancreatic Cancer Detection
An observational study of Cancer of Pancreas and Pancreas Cyst, run by Hull University Teaching Hospitals NHS Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cancer of Pancreas, Pancreas Cyst
- How many people
- 180 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 24 Oct 2018to 28 Feb 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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).
Show all 14Show fewer
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Castle Hill Hospital, Hull University Teaching Hospitals NHS Trust
Cottingham, Kingston Upon Hull, HU16 5JQ
Anthony Maraveyas, 01482 461245, anthony.maraveyas@nhs.net
About this study
Official title: 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.
Read more
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
- Keywords
- Early detection of pancreatic cancer
- Medical subject headings
- Pancreatic Neoplasms, Pancreatic Cyst
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During the recruitment phase.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2018
- Study start24 Oct 2018
- Primary completion28 Feb 2027 (estimated)
- Study completion28 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer of PancreasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hull University Teaching Hospitals NHS Trust
- Sponsor type
- Other government
- Collaborators
- University of Hull
- Responsible party
- Sponsor
- Investigators
- Anthony Maraveyas, Principal investigator, Hull University Teaching Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03536793
- Sponsor's protocol ID
- R2224
- Acronym
- TEM-PAC
- Status last verified
- Jun 2026
- First submitted
- 25 Apr 2018
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Tumour Regulatory Molecules as Markers of Malignancy in Pancreatic Cystic Lesions
- ClinicalTrials.gov ID
- NCT03536793
- Acronym / sponsor ID
- TEM-PAC / R2224
- Conditions
- Cancer of Pancreas, Pancreas Cyst
- Keywords
- Early detection of pancreatic cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Hull University Teaching Hospitals NHS TrustOther government
- Collaborators
- University of Hull
- Study start
- 24 Oct 2018 (actual)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 28 Feb 2029 (estimated)
- First posted
- 25 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (14 listed)
- 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).
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anthony Maraveyas principal investigator
Hull University Teaching Hospitals NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer of Pancreas and Pancreas Cyst, run by Hull University Teaching Hospitals NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anthony Maraveyas (01482 461245, anthony.maraveyas@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026.