ext generation sequencing in patients with pancreatic ductal adenocarcinoma (PAN-NGS). A nationwide prospective, translational cohort study
- Conditions
- Pancreatic cancer
- Registration Number
- NL-OMON21085
- Lead Sponsor
- Erasmus MC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 300
Inclusion Criteria
•Cytological or histologically confirmed PDAC, irrespective of treatment status;
•Age > 18 years and = 60 years at date of primary diagnosis;
•Performance status of ECOG 0-2;
•Estimated life expectancy of at least 12 weeks;
•Written informed consent.
Exclusion Criteria
•Unwilling to know if there are any alterations which might be associated with genetic predisposition of cancer;
•Patient with locally-advanced PDAC or local-recurrence of PDAC with no histological tissue available for NGS.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary endpoint of the study is defined as the frequency of clinically actionable alterations in PDAC patients = 60 years old.
- Secondary Outcome Measures
Name Time Method •To assess the feasibility of nationwide NGS in a clinically relevant manner in the Netherlands.<br>•To determine the impact of NGS on clinical management in PDAC patients = 60 years.<br>•To identify subgroups of PDAC patients with a high incidence of actionable genetic alterations.<br>•To identify genomic predictors of therapy response and long term oncological outcomes.<br>•To determine the potential of ctDNA for the identification of genetic alterations in pancreatic cancer patients.