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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON21085
Enrollment
300
Registered
2020-11-05
Start date
2020-11-05
Completion date
Unknown
Last updated
2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic cancer

Interventions

Peripheral blood collection and an additional biopsy in a subset of included patients.

Sponsors

Erasmus MC
Lead Sponsor

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
The primary endpoint of the study is defined as the frequency of clinically actionable alterations in PDAC patients = 60 years old.

Secondary

MeasureTime frame
• To assess the feasibility of nationwide NGS in a clinically relevant manner in the Netherlands. • To determine the impact of NGS on clinical management in PDAC patients = 60 years. • To identify subgroups of PDAC patients with a high incidence of actionable genetic alterations. • To identify genomic predictors of therapy response and long term oncological outcomes. • To determine the potential of ctDNA for the identification of genetic alterations in pancreatic cancer patients.

Contacts

Public ContactGaby Strijk

Erasmus MC

g.strijk@erasmusmc.nl010-7044331

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)