Biomarker Study in Pancreatic Neuroendocrine Tumours

NCT03130205 | Unknown

• 1 other identifier: Uppsala University Hospital
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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.

Interventions

Core Needle Biopsy PROCEDURE

Core Needle Biopsy is performed from liver metastasis.

Computed Tomography RADIATION

Computed Tomography

18F-FDG-PET RADIATION

18F Fluorodeoxyglucose Positron emission tomography

Phlebotomy PROCEDURE

3 EDTA tubes drawn from peripheral vein

Molecular genetic analysis GENETIC

Performed on biomaterial from peripheral vein and core needle biopsy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with non-resectable metastatic pancreatic neuroendocrine tumors at the Department of Endocrine Oncology, Uppsala, Sweden.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Uppsala University: lead

Study Sites (1)

Akademiska Sjukhuset

Uppsala, 75185, Sweden

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Core needle Biopsy Phlebotomy

MeSH Terms

Conditions

Neuroendocrine Tumors

Interventions

Biopsy, Large-Core Needle; Phlebotomy

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Biopsy, Needle; Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Punctures; Investigative Techniques; Blood Specimen Collection; Therapeutics

Study Officials

• Barbro Eriksson, MD PhD

  Akademiska Sjukhuset, Uppsala

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Barbro Eriksson, MD PhD

CONTACT

+46186110000; barbro.eriksson@medsci.uu.se

Joakim Crona, MD PhD

CONTACT

+46186118630; joakim.crona@medsci.uu.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Senior Attending

Study Record Dates

• First Submitted: April 6, 2017
• First Posted: April 26, 2017
• Study Start: May 1, 2017
• Primary Completion: January 1, 2021
• Study Completion: January 1, 2022
• Last Updated: August 25, 2017

Record last verified: 2017-08

Locations

SE (1)