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
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|
|Study Type :||Observational|
|Estimated Enrollment :||180 participants|
|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|
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.
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).
- 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.
- 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 ]
- 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.
- 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.
- 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 ]
- 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 ]
- 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.
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
|Contact: Anthony Maraveyas||01482 firstname.lastname@example.org|
|Castle Hill Hospital, Hull and East Yorkshire Hospitals NHS Trust||Recruiting|
|Cottingham, Kingston Upon Hull, United Kingdom, HU16 5JQ|
|Contact: Anthony Maraveyas 01482461245 email@example.com|
|Principal Investigator:||Anthony Maraveyas||Hull and East Yorkshire NHS Trust|