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DNA-mutation Analysis in Cyst Fluid of Suspected Intraductal Papillary Mucinous Neoplasia of the Pancreas

NCT03820531 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2022-12-20

No results posted yet for this study

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 KRAS/GNAS 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 HGD/carcinoma in mucinous cysts.

Conditions

  • Pancreas Cyst

Interventions

DIAGNOSTIC_TEST

Next Generation Sequencing

DNA Mutational Analysis in pancreas cyst fluid concerning KRAS/GNAS-mutations and mutations in tumor supressor genes

DIAGNOSTIC_TEST

CEA and lipase

Measuring CEA and lipase level in pancreas cyst fluid: CEA \> 192 ng/ml and lipase \> 200 U/l = mucinous cyst

DIAGNOSTIC_TEST

Cytology

Cytology in pancreas cyst fluid: mucinous versus non-mucinous cyst; LGD versus HGD/Carcinoma

DIAGNOSTIC_TEST

Histology of resected pancreas cyst

Histology of resected pancreas cyst concerning mucinous versus non-mucinous cyst, IPMN versus non-IPMN and LGD versus HGD/Carcinoma

Sponsors & Collaborators

  • University Hospital Heidelberg

    collaborator OTHER

  • Theresienkrankenhaus und St. Hedwig-Klinik GmbH

    lead OTHER

Principal Investigators

  • Christel Weiß, Prof.Dr. · University of Heidelberg, Department of Medical Statistis

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-01
Primary Completion
2022-12-01
Completion
2022-12-01

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03820531 on ClinicalTrials.gov