The Influence of Secretin Stimulated Pancreatic Secretion on ctDNA Expression in Patients With Pancreatic Ductal Adenocarcinoma: The Role of Biomarkers in Determining the Prognosis of Pancreatic Ductal Adenocarcinoma
1 other identifier
observational
39
1 country
1
Brief Summary
The goal of this study is to assess the influence of pancreatic secretion stimulation by intravenously administered secretin on circulating tumor DNA in patients with pancreatic ductal adenocarcinoma. Additional aim of the study is to analyse a role of specific biomarkers in determining the prognosis of this disease. The main question o answer is: Does intravenous secretin administration potentiate the release of circulating tumor DNA in patients with pancreatis ductal adenocarcinoma? Additional question is: Is there a biomarker specific and sensitive enough to help to predict the prognosis and the at the time status of the disease? Participants scheduled for surgical treament due to pancreatic ductal adenocarcinoma will be included and stimulated with intravenously administered secretin, their peripheral blood samples will then be analyzed for ctDNA levels.
Trial Health
Trial Health Score
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participants targeted
Target at P25-P50 for all trials
Started Feb 2025
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 29, 2025
CompletedFirst Posted
Study publicly available on registry
February 4, 2025
CompletedStudy Start
First participant enrolled
February 9, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 1, 2027
February 4, 2025
January 1, 2025
1.4 years
January 29, 2025
February 3, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Plasmatic level of circulating tumor DNA
ng/ml
During the surgery: 3, 8, 13, 18 minutes after secretin administration; 3, 6 and 12 months after surgery
Secondary Outcomes (1)
Plasmatic levels of mRNA, miRNA, S100 proteins, siRNA, exoRNA.
During the surgery: 3, 8, 13, 18 minutes after secretin administration; 3, 6 and 12 months after surgery.
Study Arms (1)
Patients with pancreatic ductal adenocarcinoma scheduled for surgery
Both male and female patients of all age diagnosed with pancreatic ductal adenocarcinoma and indicated for surgical treatment by multidisciplinary tumor board. Patients with and without previously completed chemotherapy will be included.
Interventions
16 micrograms of liquid secretin will be one-time intravenously administered to patients with PDAC during the first hour of surgery. Four peripheral blood samples will then be collected. Plasmatic levels of ctDNA will be measured. Plasmatic levels of biomarkers such as mRNA, miRNA, siRNA, exoRNA, S100 proteins and amino acids, isolated from the same blood samples, will be measured and analyzed in correlation to tumor volumometry, survival rate etc. in specific intervals during follow-ups.
Eligibility Criteria
Subjects will be recruited as citizens of either Czech or Slovak republic, in any age-range, examined at various departments such as Gastroenterology, Surgery, Radiology in various healthcare facilities, recommended for multidisciplinary tumor board as a part of the Pancreatic Surgery Center, Department of Surgery, Military University Hospital in Prague.
You may qualify if:
- patients diagnosed with pancreatic ductal adenocarcinoma
- patients indicated for surgery by multidisciplinary tumor board
- patients without previously administered chemotherapy
- patients with previously administered chemotherapy
You may not qualify if:
- patients diagnosed with pancreatic ductal adenocarcinoma, at the time indicated for different than surgical therapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Surgery, Military University Hospital in Prague
Prague, 16902, Czechia
Related Publications (12)
Sarantis P, Koustas E, Papadimitropoulou A, Papavassiliou AG, Karamouzis MV. Pancreatic ductal adenocarcinoma: Treatment hurdles, tumor microenvironment and immunotherapy. World J Gastrointest Oncol. 2020 Feb 15;12(2):173-181. doi: 10.4251/wjgo.v12.i2.173.
PMID: 32104548BACKGROUNDUshio J, Kanno A, Ikeda E, Ando K, Nagai H, Miwata T, Kawasaki Y, Tada Y, Yokoyama K, Numao N, Tamada K, Lefor AK, Yamamoto H. Pancreatic Ductal Adenocarcinoma: Epidemiology and Risk Factors. Diagnostics (Basel). 2021 Mar 20;11(3):562. doi: 10.3390/diagnostics11030562.
PMID: 33804776BACKGROUNDKamisawa T, Wood LD, Itoi T, Takaori K. Pancreatic cancer. Lancet. 2016 Jul 2;388(10039):73-85. doi: 10.1016/S0140-6736(16)00141-0. Epub 2016 Jan 30.
PMID: 26830752BACKGROUNDImaoka H, Shimizu Y, Senda Y, Natsume S, Mizuno N, Hara K, Hijioka S, Hieda N, Tajika M, Tanaka T, Ishihara M, Niwa Y, Yamao K. Post-adjuvant chemotherapy CA19-9 levels predict prognosis in patients with pancreatic ductal adenocarcinoma: A retrospective cohort study. Pancreatology. 2016 Jul-Aug;16(4):658-64. doi: 10.1016/j.pan.2016.04.007. Epub 2016 Apr 22.
PMID: 27178104BACKGROUNDO'Neill RS, Stoita A. Biomarkers in the diagnosis of pancreatic cancer: Are we closer to finding the golden ticket? World J Gastroenterol. 2021 Jul 14;27(26):4045-4087. doi: 10.3748/wjg.v27.i26.4045.
PMID: 34326612BACKGROUNDTuranli B, Yildirim E, Gulfidan G, Arga KY, Sinha R. Current State of "Omics" Biomarkers in Pancreatic Cancer. J Pers Med. 2021 Feb 14;11(2):127. doi: 10.3390/jpm11020127.
PMID: 33672926BACKGROUNDWolrab D, Jirasko R, Cifkova E, Horing M, Mei D, Chocholouskova M, Peterka O, Idkowiak J, Hrnciarova T, Kuchar L, Ahrends R, Brumarova R, Friedecky D, Vivo-Truyols G, Skrha P, Skrha J, Kucera R, Melichar B, Liebisch G, Burkhardt R, Wenk MR, Cazenave-Gassiot A, Karasek P, Novotny I, Greplova K, Hrstka R, Holcapek M. Lipidomic profiling of human serum enables detection of pancreatic cancer. Nat Commun. 2022 Jan 10;13(1):124. doi: 10.1038/s41467-021-27765-9.
PMID: 35013261BACKGROUNDLuo J. KRAS mutation in pancreatic cancer. Semin Oncol. 2021 Feb;48(1):10-18. doi: 10.1053/j.seminoncol.2021.02.003. Epub 2021 Feb 23.
PMID: 33676749BACKGROUNDLan B, Zeng S, Grutzmann R, Pilarsky C. The Role of Exosomes in Pancreatic Cancer. Int J Mol Sci. 2019 Sep 4;20(18):4332. doi: 10.3390/ijms20184332.
PMID: 31487880BACKGROUNDWaters AM, Der CJ. KRAS: The Critical Driver and Therapeutic Target for Pancreatic Cancer. Cold Spring Harb Perspect Med. 2018 Sep 4;8(9):a031435. doi: 10.1101/cshperspect.a031435.
PMID: 29229669BACKGROUNDAfroze S, Meng F, Jensen K, McDaniel K, Rahal K, Onori P, Gaudio E, Alpini G, Glaser SS. The physiological roles of secretin and its receptor. Ann Transl Med. 2013 Oct;1(3):29. doi: 10.3978/j.issn.2305-5839.2012.12.01.
PMID: 25332973BACKGROUNDPerets R, Greenberg O, Shentzer T, Semenisty V, Epelbaum R, Bick T, Sarji S, Ben-Izhak O, Sabo E, Hershkovitz D. Mutant KRAS Circulating Tumor DNA Is an Accurate Tool for Pancreatic Cancer Monitoring. Oncologist. 2018 May;23(5):566-572. doi: 10.1634/theoncologist.2017-0467. Epub 2018 Jan 25.
PMID: 29371474BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jan Bureš, prof., MD, CSc., FCMA
Military University Hospital in Prague
- PRINCIPAL INVESTIGATOR
Kristýna Pončáková, MD
Military University Hospital in Prague
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 29, 2025
First Posted
February 4, 2025
Study Start
February 9, 2025
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
February 1, 2027
Last Updated
February 4, 2025
Record last verified: 2025-01