BIOmarkers in Patients With Pancreatic Cancer ("BIOPAC")

Pancreatic Cancer Clinical Trial

— BIOPAC  

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?

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03311776
• Other study ID #: GI 0815
• Status: Recruiting
• Start date: July 3, 2008
• Est. completion date: July 2, 2035

Study information

• Verified date: February 2023
• Source: Herlev Hospital
• Contact: Julia Sidenius Johansen, MD, DMsc
• Phone: +45 38689241
• Email: Julia.Sidenius.Johansen[@]regionh.dk
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: July 2, 2035
• Est. primary completion date: July 2, 2035
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Locations

Country	Name	City	State
Denmark	Herlev & Gentofte Hospital	Herlev

Sponsors (1)

Lead Sponsor	Collaborator
Inna Chen, MD

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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