BIOmarkers in Patients With Pancreatic Cancer ("BIOPAC")
BIOPAC
BIOmarkers in Patients With PAncreatic Cancer (BIOPAC) - Can They Provide New Information of the Disease and Improve Diagnosis and Prognosis of the Patients?
1 other identifier
observational
5,000
1 country
1
Brief Summary
No validated biomarkers to identify PC at an early stage and to predict treatment outcomes in the individual patient exist. The objective of the present study is to find diagnostic, prognostic and predictive biomarkers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2008
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 3, 2008
CompletedFirst Submitted
Initial submission to the registry
October 6, 2017
CompletedFirst Posted
Study publicly available on registry
October 17, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 2, 2035
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 2, 2035
March 1, 2023
February 1, 2023
27 years
October 6, 2017
February 28, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Diagnostic biomarkers
Biomarker analyses include, but are not limited to a range of molecules with different characteristics such as DNA, Single Nucleotide Polymorphism (SNPs), RNA, microRNA, proteins and metabolites.
baseline
Prognostic biomarkers
Biomarker analyses include, but are not limited to a range of molecules with different characteristics such as DNA, Single Nucleotide Polymorphism (SNPs), RNA, microRNA, proteins and metabolites.
baseline and through study completion, an average of 1 year
Predictive biomarkers
Biomarker analyses include, but are not limited to a range of molecules with different characteristics such as DNA, Single Nucleotide Polymorphism (SNPs), RNA, microRNA, proteins and metabolites.
baseline and through study completion, an average of 1 year
Eligibility Criteria
Patients with localized, locally advanced or metastatic PC treated in routine care in six hospitals in Denmark as well as operated patients who were suspicious for PC but without evidence of cancer in histology.
You may qualify if:
- Age \> 18 years
- Histologically verified PC (ductal adenocarcinoma) or ampullary adenocarcinoma in a resected specimen; or histopathological confirmation of carcinoma in patients not undergoing surgery in the setting of clinical and radiological characteristics which, together with the pathology, are consistent with a diagnosis of PC independently of stage
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Inna Chen, MDlead
Study Sites (1)
Herlev & Gentofte Hospital
Herlev, 2730, Denmark
Related Publications (5)
Pedersen RS, Nissen NI, Jensen C, Thorlacius-Ussing J, Manon-Jensen T, Olesen ML, Langholm LL, Diab HMH, Jorgensen LN, Hansen CP, Chen IM, Johansen JS, Karsdal MA, Willumsen N. Plasma Kallikrein-Activated TGF-beta Is Prognostic for Poor Overall Survival in Patients with Pancreatic Ductal Adenocarcinoma and Associates with Increased Fibrogenesis. Biomolecules. 2022 Sep 17;12(9):1315. doi: 10.3390/biom12091315.
PMID: 36139154DERIVEDNissen NI, Kehlet S, Johansen AZ, Chen IM, Karsdal M, Johansen JS, Diab HMH, Jorgensen LN, Sun S, Manon-Jensen T, He Y, Langholm L, Willumsen N. Noninvasive prognostic biomarker potential of quantifying the propeptides of Type XI collagen alpha-1 chain (PRO-C11) in patients with pancreatic ductal adenocarcinoma. Int J Cancer. 2021 Jul 1;149(1):228-238. doi: 10.1002/ijc.33551. Epub 2021 Mar 22.
PMID: 33687786DERIVEDRasmussen LS, Yilmaz MK, Falkmer UG, Poulsen LO, Bogsted M, Christensen HS, Bojesen SE, Jensen BV, Chen IM, Johansen AZ, Hansen CP, Hasselby JP, Hollander N, Nielsen SE, Andersen F, Bjerregaard JK, Pfeiffer P, Johansen JS. Pre-treatment serum vitamin D deficiency is associated with increased inflammatory biomarkers and short overall survival in patients with pancreatic cancer. Eur J Cancer. 2021 Feb;144:72-80. doi: 10.1016/j.ejca.2020.10.038. Epub 2020 Dec 17.
PMID: 33341448DERIVEDChen IM, Willumsen N, Dehlendorff C, Johansen AZ, Jensen BV, Hansen CP, Hasselby JP, Bojesen SE, Pfeiffer P, Nielsen SE, Hollander NH, Yilmaz MK, Karsdal M, Johansen JS. Clinical value of serum hyaluronan and propeptide of type III collagen in patients with pancreatic cancer. Int J Cancer. 2020 May 15;146(10):2913-2922. doi: 10.1002/ijc.32751. Epub 2019 Nov 11.
PMID: 31642523DERIVEDMellby LD, Nyberg AP, Johansen JS, Wingren C, Nordestgaard BG, Bojesen SE, Mitchell BL, Sheppard BC, Sears RC, Borrebaeck CAK. Serum Biomarker Signature-Based Liquid Biopsy for Diagnosis of Early-Stage Pancreatic Cancer. J Clin Oncol. 2018 Oct 1;36(28):2887-2894. doi: 10.1200/JCO.2017.77.6658. Epub 2018 Aug 14.
PMID: 30106639DERIVED
Biospecimen
Blood samples and tissue from primary tumor and/or metastasis
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
October 6, 2017
First Posted
October 17, 2017
Study Start
July 3, 2008
Primary Completion (Estimated)
July 2, 2035
Study Completion (Estimated)
July 2, 2035
Last Updated
March 1, 2023
Record last verified: 2023-02