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Tumour Regulatory Molecules in Early Pancreatic Cancer Detection

Study acronym: TEM-PAC
StatusRecruiting
PhaseNot specified
Started
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Record History

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  1. Minor Re-verified, no change to tracked fieldsv12
  2. Notable Primary completion date: Feb 28, 2026 to Feb 28, 2027v11
  3. Minor Re-verified, no change to tracked fieldsv10
  4. Notable Primary completion date: Feb 29, 2024 to Feb 28, 2026
    • Study completion date: Feb 29, 2024 to Feb 28, 2029
    • Site contact updated
    v9
  5. Minor Re-verified, no change to tracked fieldsv8
Show 6 earlier versionsHide 6 earlier versions
  1. Notable Primary completion date: May 31, 2022 to Feb 29, 2024v7
  2. Minor Re-verified, no change to tracked fieldsv6
  3. Notable Primary endpoint revisedv5 Show 7 more changesShow less
    • Primary completion date: May 2022 to May 31, 2022
    • Study completion date: May 2022 to Feb 29, 2024
    • Start date: Dec 3, 2018 to Oct 24, 2018
    • Secondary endpoints shortened, about 107 words
    • Study site revised
    • Eligibility criteria expanded, about 2 words
    • Study title shortened, about 1 word
  4. Minor Study Status, Referencesv4
  5. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Sep 2018 to Dec 3, 2018
    v3
  6. Notable Start date: Jun 2018 to Sep 2018v2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT03536793
Lead Sponsor Hull University Teaching Hospitals NHS Trust
Collaborators: University of Hull
Conditions
(from sponsor)
Cancer of Pancreas, Pancreas Cyst
Related terms Pancreatic Cyst, Pancreatic Neoplasms
Enrollment 180 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov