BIOmarkers in Patients With Pancreatic Cancer ("BIOPAC")

Recruiting

• Conditions: Pancreatic Cancer

• Registration Number: NCT03311776
• Lead Sponsor: Inna Chen, MD

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.

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.

Study Timeline

• Study Start: 2008-07-03
• Study First Submitted: 2017-10-06
• Study First Submitted QC: 2017-10-11
• Study First Posted: 2017-10-17
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-28
• Last Update Posted: 2023-03-01
• Primary Completion: 2035-07-02
• Study Completion: 2035-07-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 5000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prognostic biomarkers	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.
Diagnostic biomarkers	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.
Predictive biomarkers	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.

Trial Locations

Locations (1)

Herlev & Gentofte Hospital; 🇩🇰 Herlev, Denmark