Biomarker Study in Pancreatic Neuroendocrine Tumours

Neuroendocrine Tumors Clinical Trial

— PROGRESS  

Official title:

Prospective Longitudinal Biomarker Study in Pancreatic Neuroendocrine Tumours

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03130205
• Other study ID #: Uppsala University Hospital
• Status: Recruiting
• Phase: N/A
• First received: April 6, 2017
• Last updated: August 24, 2017
• Start date: May 1, 2017
• Est. completion date: January 1, 2022

Study information

• Verified date: August 2017
• Source: Uppsala University
• Contact: Barbro Eriksson, MD PhD
• Phone: +46186110000
• Email: barbro.eriksson[@]medsci.uu.se
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: January 1, 2022
• Est. primary completion date: January 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age =18 years

• Informed consent

• WHO performance status =2

• Progressive disease (as defined by the local investigator) or newly diagnosed disease (defined as prior to medical or oncological intervention except for somatostatin analogue treatment).

• Pathology confirmed diagnosis of pancreatic or duodenal neuroendocrine tumour WHO G1-G3.

o Exception: In newly diagnosed patients with high suspicion of PNET based on clinical and radiological parameters where tissue sample have not yet been obtained. These patients may be included and subsequently excluded if pathology cannot confirm NET.

• Biopsy procedure not associated with inappropriate risk as determined by the responsible physician.

Exclusion Criteria:

• Patient does not consent

• Permanent risk factors for biopsy

• Long term treatment with anticoagulant that cannot be temporarily paused without unacceptable risk.

• Permanent coagulation disorder

• Pregnancy or no contraceptive in fertile women.

Related Conditions & MeSH terms

• Carcinoid Tumor
• Neuroendocrine Tumors

Intervention

Procedure:
• Core Needle Biopsy
Core Needle Biopsy is performed from liver metastasis.

Radiation:
• Computed Tomography
Computed Tomography
• 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

Locations

Country	Name	City	State
Sweden	Akademiska Sjukhuset	Uppsala

Sponsors (1)

Lead Sponsor	Collaborator
Uppsala University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation between FDG-PET and tumor biology	18F-FDG-PET SUVmax correlation to Ki67 index (determined as percentage of tumor cells with positive Ki67 imunohistochemical staining).	Through study completion, an average of 3 years.