NCT03130205

Biomarker Study in Pancreatic Neuroendocrine Tumours

Prospective Longitudinal Biomarker Study in Pancreatic Neuroendocrine Tumours

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 30 (estimated)
• Sponsor: Uppsala University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The biology of pancreatic neuroendocrine tumors can change during the disease course. This evolution of disease can manifest through increases in tumor proliferation rate, resistance to medical therapy and/or a change in tumor hormone secretion. This study aims to characterize how the biology of pancreatic neuroendocrine tumors change over time, measured by; patient symptoms, biochemistry, contrast enhanced computed tomography, FDG-PET and core needle biopsy with histopathological analysis (Ki67 index and tumor cell differentiation). Uptake on 18F-FDG-PET will be correlated directly to tumor cell proliferation rate. Fraction of patients with spatial heterogeneity in FDG uptake as well as metachronous changes in all collected data will be documented. Biomaterial from whole blood and core needle biopsies will be characterized on the molecular level, and those findings will be integrated to the above specified clinical parameters.

Conditions

• Neuroendocrine Tumors

Interventions

Type	Name	Description
PROCEDURE	Core Needle Biopsy	Core Needle Biopsy is performed from liver metastasis.
RADIATION	Computed Tomography	Computed Tomography
RADIATION	18F-FDG-PET	18F Fluorodeoxyglucose Positron emission tomography
PROCEDURE	Phlebotomy	3 EDTA tubes drawn from peripheral vein
GENETIC	Molecular genetic analysis	Performed on biomaterial from peripheral vein and core needle biopsy

Timeline

• Start date: 2017-05-01
• Primary completion: 2021-01-01
• Completion: 2022-01-01
• First posted: 2017-04-26
• Last updated: 2017-08-25

Locations

1 site across 1 country: Sweden