Biomarker Study in Pancreatic Neuroendocrine Tumours

NCT ID: NCT03130205

Last Updated: 2017-08-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-05-01

Study Completion Date

2022-01-01

Brief Summary

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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.

Detailed Description

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Conditions

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Neuroendocrine Tumors

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Core Needle Biopsy

Core Needle Biopsy is performed from liver metastasis.

Intervention Type PROCEDURE

Computed Tomography

Computed Tomography

Intervention Type RADIATION

18F-FDG-PET

18F Fluorodeoxyglucose Positron emission tomography

Intervention Type RADIATION

Phlebotomy

3 EDTA tubes drawn from peripheral vein

Intervention Type PROCEDURE

Molecular genetic analysis

Performed on biomaterial from peripheral vein and core needle biopsy

Intervention Type GENETIC

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Uppsala University

OTHER

Sponsor Role lead

Responsible Party

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Barbro Eriksson

Professor, Senior Attending

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Barbro Eriksson, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Akademiska Sjukhuset, Uppsala

Locations

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Akademiska Sjukhuset

Uppsala, , Sweden

Site Status RECRUITING

Countries

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Sweden

Central Contacts

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Barbro Eriksson, MD PhD

Role: CONTACT

+46186110000

Joakim Crona, MD PhD

Role: CONTACT

+46186118630

Facility Contacts

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Barbro Eriksson, MD PhD

Role: primary

+46186110000

Joakim Crona, MD PhD

Role: backup

+46186118630

Other Identifiers

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Uppsala University Hospital

Identifier Type: -

Identifier Source: org_study_id

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