ext generation sequencing in patients with pancreatic ductal adenocarcinoma (PAN-NGS). A nationwide prospective, translational cohort study.

Recruiting

Conditions: pancreatic cancer
pancreatic ductal adenocarcinoma
10015674

Registration Number: NL-OMON51960

Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

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 invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main endpoint is determining the percentage of patients with clinically<br /><br>actionable genetic alterations. These alterations are defined as (1) a<br /><br>pathogenic variant that is target of an approved drug in any cancer indication<br /><br>or predicts sensitivity to an approved drug in any cancer indication (e.g. MSI<br /><br>and pembrolizumab), (2) a pathogenic variant that is in the same pathway as a<br /><br>variant that is the target of an approved drug in any cancer indication or (3)<br /><br>a pathogenic variant that has compelling clinical or biological evidence<br /><br>supporting being predictive of response to a drug in PDAC. Clinically<br /><br>actionable mutations are selected using the OncoKB database52 and scientific<br /><br>literature. </p><br>

Secondary Outcome Measures