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Trial record 68 of 2839 for:    Pancreatic Cancer

Urinary TF and Endo180 in Early Pancreatic Cancer Detection (TEM-PAC)

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ClinicalTrials.gov Identifier: NCT03536793
Recruitment Status : Recruiting
First Posted : May 25, 2018
Last Update Posted : July 15, 2019
Sponsor:
Collaborator:
University of Hull
Information provided by (Responsible Party):
Hull and East Yorkshire Hospitals NHS Trust

Brief Summary:

This study will measure the levels of uTF and Endo180 in patients with pancreatic cancer, and also in patients with pancreatic cysts in which cancer may be suspected, to determine the accuracy of these tests in detecting early stage pancreatic cancer. 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.

Precancerous 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.

The investigators propose two potential markers of early pancreatic cancer: urinary tissue factor (uTF) and Endo180. ELISA tests have been developed to measure the levels of TF in urinary microvesicles and Endo180 concentration in urine, serum and cystic fluid samples.


Condition or disease
Cancer of Pancreas Pancreas Cyst

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Study Type : Observational
Estimated Enrollment : 180 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study of uTF and Endo180 as Markers of Early Malignancy in Pancreatic Cystic Lesions
Actual Study Start Date : December 3, 2018
Estimated Primary Completion Date : May 2022
Estimated Study Completion Date : May 2022

Resource links provided by the National Library of Medicine


Group/Cohort
Pancreatic cysts
Samples (urine, serum and cystic fluid) will be taken from 50 patients with pancreatic cysts on follow-up. These will be sent to either the University of Hull or a commercial laboratory for analysis of Endo180 and urinary TF, respectively. 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).
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 their 8-week review subsequent to cholecystectomy (normal control subgroup).



Primary Outcome Measures :
  1. Accuracy of uTF and Endo180 assays in detection of pancreatic cancer [ Time Frame: Through study completion, an average of 4 years ]
    The primary aim is to assess the accuracy of the uTF and Endo180 assays in the detection of pancreatic cancer. Patients with a pancreatic cancer diagnosis will be compared to controls to determine if a suitable cut-off for the assays can be found.


Secondary Outcome Measures :
  1. Ascertain whether the determined cut-off for each assay is effective in the classification of precancerous cystic lesions. [ Time Frame: Through study completion, an average of 4 years ]
  2. Compare Endo180 specificity, sensitivity, diagnostic accuracy, etc. to current conventional assays performed on cystic fluid. [ Time Frame: Through study completion, an average of 4 years ]
    The results from the Endo180 assays will be compared to results from conventional assays performed on cystic fluid such as CEA, mucin and amylase.

  3. Assess the amount of fluid required for diagnostics and how many of the cysts are deemed suitable for this approach. [ Time Frame: 2 years ]
    This will be part of a feasibility measure to test whether such assays on pancreatic cystic fluid samples can be used in a larger, prospective study.

  4. Compare circulating levels of Endo180 detected in serum from patients with cystic lesions to those in other groups. [ Time Frame: Through study completion, an average of 4 years ]
  5. Compare the Endo180 urinary profile in benign vs malignant pathology, and to the profile obtained for uTF. [ Time Frame: Through study completion, an average of 4 years ]
  6. Capture serial data of how many cysts come through the unit and how many of these cysts can be studied. [ Time Frame: 2 years ]
    This will be part of a feasibility measure to test whether such assays on pancreatic cystic fluid samples can be used in a larger, prospective study.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Potential participants will be identified through the pancreatic multidisciplinary team (MDT) meetings or outpatient clinic. Once eligibility has been confirmed, they will be approached by a member of the research team.

The majority of patients with resectable pancreatic cancer will be inpatients and therefore will be approached by a member of the research team on the hospital ward. Patients with non-resectable pancreatic cancer will be approached at their scheduled outpatient clinic appointment.

Participants with pancreatic cysts and those that will be in the benign/ control cohort will also be approached during outpatient clinic appointments.

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 had cholecystectomy 8 weeks earlier (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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03536793


Contacts
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Contact: Anthony Maraveyas 01482 461245 anthony.maraveyas@hey.nhs.uk

Locations
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United Kingdom
Castle Hill Hospital, Hull and East Yorkshire Hospitals NHS Trust Recruiting
Cottingham, Kingston Upon Hull, United Kingdom, HU16 5JQ
Contact: Anthony Maraveyas    01482461245    anthony.maraveyas@hey.nhs.uk   
Sponsors and Collaborators
Hull and East Yorkshire Hospitals NHS Trust
University of Hull
Investigators
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Principal Investigator: Anthony Maraveyas Hull and East Yorkshire NHS Trust

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Responsible Party: Hull and East Yorkshire Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT03536793     History of Changes
Other Study ID Numbers: R2224
First Posted: May 25, 2018    Key Record Dates
Last Update Posted: July 15, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hull and East Yorkshire Hospitals NHS Trust:
Early detection of pancreatic cancer
Endo180
Urinary tissue factor
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Pancreatic Cyst
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Cysts