2008-07-03
2035-07-02
2035-07-02
5000
NCT03311776
Herlev Hospital
Herlev Hospital
OBSERVATIONAL
BIOmarkers in Patients With Pancreatic Cancer (ȫIOPAC")
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.
The overall survival of patients with pancreatic cancer (PC) is dismal and has only improved slightly during the last decades primarily due to combination chemotherapy. Early detection of PC is difficult and less than 25% of all PC patients are operated. 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, which can be used to 1) diagnose PC early in the disease course with high specificity and sensitivity, 2) improve prognostication, or 3) predict and monitor treatment effectiveness and tolerability for the individual patient. BIOPAC is an observational and translational open cohort study with prospective collection of biological materials and clinical data in patients with PC treated in routine care and also patients who were suspicious for malignancy in the pancreas but then operated without evidence of malignancy. Patients contribute with blood samples (i.e. serum, EDTA plasma and buffy coat, and blood in PAXgeneRNA tubes) before operation or start of adjuvant or palliative chemotherapy and during treatment with blood sampling before 2. cycle of chemotherapy and longitudinally every time of CT scan until disease progression. This schedule is repeated if patients are treated with subsequent lines of chemotherapy. The patients are followed until death. Demographics, disease characteristics, comorbidities and lifestyle factors are registered at inclusion; weight and performance status at each treatment cycle; routine blood tests (i.e. haematology, creatinine, liver enzymes, bilirubin, carbohydrate antigen 19-9, C-reactive protein); type of operation; types of chemotherapy and number of cycles given; date of disease recurrence in operated patients; date of disease progression for each line of chemotherapy; and date of death. Biomarker analyses will include a range of molecules with different characteristics such as DNA, Single Nucleotide Polymorphism (SNPs), RNA, microRNA, proteins and metabolites. Data will be analysed using appropriate methods and statistical analyses.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2017-10-06 | N/A | 2023-02-28 |
2017-10-11 | N/A | 2023-03-01 |
2017-10-17 | N/A | 2023-02 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
N/A
Allocation:
N/A
Interventional Model:
N/A
Masking:
N/A
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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 |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Julia Sidenius Johansen, MD, DMsc Phone Number: +45 38689241 Email: Julia.Sidenius.Johansen@regionh.dk |
Study Contact Backup Name: Inna Markovna Chen, MD Phone Number: +45 38682898 Email: Inna.Chen@regionh.dk |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
19 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
NPCF was founded on May 29, 2009 and is a 501(c)(3) organization. All donations are tax deductible.
The information and services provided by the National Pancreatic Cancer Foundation are for informational purposes only. The information and services are not intended to be substitutes for professional medical advice, diagnosis or treatment. The National Pancreatic Cancer Foundation does not recommend nor endorse any specific physicians, products or treatments even though they may be mentioned on this site.
Copyright © 2024 – National Pancreatic Cancer Foundation | All Rights Reserved
