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BIOmarkers in Patients With Pancreatic Cancer ("BIOPAC") (BIOPAC)

This study is currently recruiting participants.
Verified October 2017 by Benny Vittrup Jensen, Herlev Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT03311776
First Posted: October 17, 2017
Last Update Posted: October 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Benny Vittrup Jensen, Herlev Hospital
  Purpose
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.

Condition
Pancreatic Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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?

Resource links provided by NLM:


Further study details as provided by Benny Vittrup Jensen, Herlev Hospital:

Primary Outcome Measures:
  • Diagnostic biomarkers [ Time Frame: baseline ]
    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.

  • Prognostic biomarkers [ Time Frame: baseline and through study completion, an average of 1 year ]
    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.

  • Predictive biomarkers [ Time Frame: baseline and through study completion, an average of 1 year ]
    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.


Biospecimen Retention:   Samples With DNA
Blood samples and tissue from primary tumor and/or metastasis

Estimated Enrollment: 5000
Actual Study Start Date: July 3, 2008
Estimated Study Completion Date: July 2, 2035
Estimated Primary Completion Date: July 2, 2035 (Final data collection date for primary outcome measure)
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
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.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

• None

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03311776


Contacts
Contact: Julia Sidenius Johansen, MD, DMsc +45 38689241 Julia.Sidenius.Johansen@regionh.dk
Contact: Inna Markovna Chen, MD +45 38682898 Inna.Chen@regionh.dk

Locations
Denmark
Herlev & Gentofte Hospital Recruiting
Herlev, Denmark, 2730
Contact: Julia Sidenius Johansen, MD, DMsc    +45 38689241    Julia.Sidenius.Johansen@regionh.dk   
Contact: Inna Markovna Chen, MD    +45 38682898    Inna.Chen@regionh.dk   
Sponsors and Collaborators
Herlev Hospital
  More Information

Responsible Party: Benny Vittrup Jensen, MD, Herlev Hospital
ClinicalTrials.gov Identifier: NCT03311776     History of Changes
Other Study ID Numbers: GI 0815
First Submitted: October 6, 2017
First Posted: October 17, 2017
Last Update Posted: October 17, 2017
Last Verified: October 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Benny Vittrup Jensen, Herlev Hospital:
Pancreatic cancer
Biomarkers
Biobank
Diagnostic biomarkers
Predictive biomarkers
Prognostic biomarkers

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases