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The value of a molecular diagnostic tool in patients with suspect pancreatic cancer

Accuracy of targeted Next-Generation Sequencing in the diagnostic process for pancreatic and periampullary cancer; a multi-center prospective cohort study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON23289
Enrollment
57
Registered
2018-01-24
Start date
2017-10-01
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Pancreatic Cancer Periampullary Cancer Pancreas kanker Periampullaire kanker

Interventions

The cytology material, obtained during fine-needle aspiration or brush, is analyzed with NGS, the molecular findings are integrated during the diagnostic process.

Sponsors

Leiden University Medical Center Department of Surgery and department of Pathology
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: • Patient with suspect pancreatic or periampullary lesion (papil; duodenum; distal bile duct); or patients with suspect cysts • Sufficient radiological images; assessed by specialized radiologist • Sufficient clinical assessment; including bilirubine levels and CA19.9 levels • Cytology sample available for pathological assessment; either obtained with FNA, brush or punction from cystic wall

Exclusion criteria

Exclusion criteria: none

Design outcomes

Primary

MeasureTime frame
Diagnostic accuracy of NGS

Secondary

MeasureTime frame
- Contribution of NGS to the diagnostic process. - Percentage of change of treatment type - Sensitivity and specificity

Contacts

Public ContactSven Mieog
j.s.d.mieog@lumc.nl

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)