Ignite Creation Date:
2024-05-06 @ 12:40 PM
Last Modification Date:
2024-10-26 @ 1:02 PM
Study NCT ID:
NCT03820531
Status:
COMPLETED
Last Update Posted:
2022-12-20
First Post:
2019-01-25
Brief Title:
DNA-mutation Analysis in Cyst Fluid of Suspected Intraductal Papillary Mucinous Neoplasia of the Pancreas
Sponsor:
Theresienkrankenhaus und St Hedwig-Klinik GmbH
Organization:
Theresienkrankenhaus und St Hedwig-Klinik GmbH
Study Overview
Official Title:
DNA-mutation Analysis by Next Generation Sequencing in Cyst Fluid of Suspected Intraductal Papillary Mucinous Neoplasia of the Pancreas Obtained by Endoscopic Ultrasound-guided Fine Needle Aspiration ZYSTEUS-Study
Status:
COMPLETED
Status Verified Date:
2022-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Diagnostic tools are needed to identify mucinous cysts for further evaluation or follow-up respectively to identify cysts with HGD or invasive cancer at an early stage for surgical resection Molecular genetic analysis of pancreatic cyst fluid is a new but rapidly evolving method to identify KRASGNAS oncogenic driver mutations in mucinous cysts and to identify tumour suppressor gene mutations which are involved in advanced cysts with HGD or carcinoma The ongoing ZYSTEUS-study tries to implement DNA mutation analysis by Next Generation Sequencing in the diagnostic algorithm of pancreas cyst evaluation The first aim is to distinguish mucinous from non-mucinous cysts The second aim is to define relevant tumour suppressor gene mutations which are relevant to distinguish between LGD and HGDcarcinoma in mucinous cysts
Detailed Description:
Intraductal papillary mucinous neoplasm IPMN with low grade dysplasia LGD can progress to high grade dysplasia HGD or invasive cancer Main duct IPMN mixed type IPMN or branch duct IPMN with high risk stigmata are highly predictive for malignancy Therefore patients in good general state should be considered for surgical resection Guidelines like the International Fukuoka Consensus Guidelines from 2017 or the European evidence-based Guidelines on Pancreatic cyst neoplasms from 2018 provide detailed recommendations on the management of IPMNs by focusing on clinical characteristics image morphology cytology and laboratory parameters However these applied guidelines still lead to surgical overtreatment of pancreas cysts based on the pathologic outcomes as neither HGD nor carcinoma is found in up to 821 of the resected cysts Cyst fluid sent for cytology usually provides adequate cellular material for analysis in only 31 of the cases and Endoscopic Ultrasound-guided forceps biopsy has not yet shown to be better than fine needle aspiration Hence further diagnostic tools are needed to identify mucinous cysts for further evaluation or follow-up respectively to identify cysts with HGD or invasive cancer at an early stage for surgical resection Molecular genetic analysis of pancreatic cyst fluid is possibly able to identify KRASGNAS oncogenic driver mutations in mucinous cysts and to identify tumour suppressor gene mutations which are involved in advanced cysts with HGD or carcinoma This workgroup described a high sensitive method of targeted Next Generation Sequencing in pancreas cyst fluid with a limit of detection of allele frequency down to 001 Further investigations of the ongoing ZYSTEUS-study are focused on the implementation of DNA mutation analysis by NGS in the diagnostic algorithm of pancreas cyst evaluation The first aim is to reliably distinguish mucinous from non-mucinous cysts respectively main duct IPMN from chronic pancreatitis with main duct dilatation as the absence of KRASGNAS-mutations is highly predictive for non-mucinous diseases The second aim is to define relevant tumour suppressor gene mutations which are relevant to differentiate LGD from HGDcarcinoma in mucinous cysts DNA mutation analysis will be compared with already established peroperative diagnostic tests of pancreas cyst fluid Measurement of CEA and lipase as well as cytology
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None