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


- candidate number28485
- NTR NumberNTR7006
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR24-jan-2018
- Secondary IDsP17.213  Protocolnummer METC
- Public TitleThe value of a molecular diagnostic tool in patients with suspect pancreatic cancer
- Scientific TitleAccuracy of targeted Next-Generation Sequencing in the diagnostic process for pancreatic and periampullary cancer; a multi-center prospective cohort study
- ACRONYMNGS study
- hypothesisTargeted Next Generation Sequencing (NGS) can distinguish benign pancreatic diseases, such as pancreatitis, from pancreatic malignancies during the diagnostic proces of patients with an uncertain diagnosis and treatment plan.
- Healt Condition(s) or Problem(s) studiedPancreatic cancer, Periampullary tumor
- 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 criterianone
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- groupFactorial
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-okt-2017
- planned closingdate1-jan-2020
- Target number of participants57
- InterventionsThe cytology material, obtained during fine-needle aspiration or brush, is analyzed with NGS, the molecular findings are integrated during the diagnostic process.
- Primary outcomeDiagnostic accuracy of NGS
- Secondary outcome- Contribution of NGS to the diagnostic process.
- Percentage of change of treatment type
- Sensitivity and specificity
- TimepointsAfter patient inclusion is complete
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMD, PhD Sven Mieog
- CONTACT for SCIENTIFIC QUERIESMD, PhD Sven Mieog
- Sponsor/Initiator Leiden University Medical Center Department of Surgery and department of Pathology
- Funding
(Source(s) of Monetary or Material Support)
Bas Mulder Award (grant UL2015-7665) from the Alpe d'HuZes foundation/Dutch Cancer Society
- PublicationsPrior publication: https://www.ncbi.nlm.nih.gov/pubmed/28775172
- Brief summaryDetermination of the added value of Targeted Next-Generation Sequencing in the diagnostic process of patients with a suspect lesion in or around the pancreas, whose morphological assessment of the preoperative cytology sample is benign or inconclusive.
- Main changes (audit trail)
- RECORD24-jan-2018 - 10-feb-2018


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