AzTrials
AzTrials

Pancreatic CancerBIOPACNCT03311776

BIOmarkers in Patients With Pancreatic Cancer ("BIOPAC")

An observational study of Pancreatic Cancer, run by Inna Chen, MD at 1 site in Denmark.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Pancreatic Cancer
How many people
5,000 participants
Where
1 siteDenmark
Study dates
3 Jul 2008to 2 Jul 2035
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • Adult, Older adult

Study population: 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.

Who may be able to join

  • 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

Who cannot join

  • None

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Julia Sidenius Johansen, MD, DMsc contact

+45 38689241

Julia.Sidenius.Johansen@regionh.dk

Inna Markovna Chen, MD contact

+45 38682898

Inna.Chen@regionh.dk

Denmark1 site, 1 recruiting

  • Herlev & Gentofte Hospital

    Herlev, 2730

    Julia Sidenius Johansen, MD, DMsc, +45 38689241, Julia.Sidenius.Johansen@regionh.dk

    Inna Markovna Chen, MD, +45 38682898, Inna.Chen@regionh.dk

    Recruiting

Other trials in Denmark

About this study

Official title: BIOmarkers in Patients With PAncreatic Cancer (BIOPAC) - Can They Provide New Information of the Disease and Improve Diagnosis and Prognosis of the Patients?

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.

Read the detailed description

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.

Keywords
Pancreatic cancer, Biomarkers, Biobank, Diagnostic biomarkers, Predictive biomarkers, Prognostic biomarkers
Medical subject headings
Pancreatic Neoplasms

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: baseline

  2. 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.

    Measured: baseline and through study completion, an average of 1 year

  3. 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.

    Measured: baseline and through study completion, an average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Oct 2017
  2. Study start3 Jul 2008
  3. Primary completion2 Jul 2035 (estimated)
  4. Study completion2 Jul 2035 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
5,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03311776
Sponsor's protocol ID
GI 0815
Acronym
BIOPAC
Status last verified
Feb 2023
First submitted
6 Oct 2017
Last updated
1 Mar 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 36139154

  • Nissen 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.

    PubMed 33687786

  • Rasmussen 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.

    PubMed 33341448

  • Chen 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.

    PubMed 31642523

  • Mellby 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.

    PubMed 30106639

Questions about this trial

What is this clinical trial studying?

An observational study of Pancreatic Cancer, run by Inna Chen, MD at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 1 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Julia Sidenius Johansen, MD, DMsc (+45 38689241, Julia.Sidenius.Johansen@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Diagnostic biomarkers (time frame: baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03311776, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in