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Biomarker Study in Pancreatic Neuroendocrine Tumours (PROGRESS)

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ClinicalTrials.gov Identifier: NCT03130205
Recruitment Status : Recruiting
First Posted : April 26, 2017
Last Update Posted : August 25, 2017
Sponsor:
Information provided by (Responsible Party):
Barbro Eriksson, Uppsala University

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.

Condition or disease Intervention/treatment
Neuroendocrine Tumors Procedure: Core Needle Biopsy Radiation: Computed Tomography Radiation: 18F-FDG-PET Procedure: Phlebotomy Genetic: Molecular genetic analysis

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Longitudinal Biomarker Study in Pancreatic Neuroendocrine Tumours
Actual Study Start Date : May 1, 2017
Estimated Primary Completion Date : January 1, 2021
Estimated Study Completion Date : January 1, 2022



Intervention Details:
  • 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


Primary Outcome Measures :
  1. Correlation between FDG-PET and tumor biology [ Time Frame: Through study completion, an average of 3 years. ]
    18F-FDG-PET SUVmax correlation to Ki67 index (determined as percentage of tumor cells with positive Ki67 imunohistochemical staining).


Biospecimen Retention:   Samples With DNA
Core needle Biopsy Phlebotomy


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with non-resectable metastatic pancreatic neuroendocrine tumors at the Department of Endocrine Oncology, Uppsala, Sweden.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03130205


Contacts
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Contact: Barbro Eriksson, MD PhD +46186110000 barbro.eriksson@medsci.uu.se
Contact: Joakim Crona, MD PhD +46186118630 joakim.crona@medsci.uu.se

Locations
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Sweden
Akademiska Sjukhuset Recruiting
Uppsala, Sweden, 75185
Contact: Barbro Eriksson, MD PhD    +46186110000    barbro.eriksson@medsci.uu.se   
Contact: Joakim Crona, MD PhD    +46186118630    joakim.crona@medsci.uu.se   
Sponsors and Collaborators
Uppsala University
Investigators
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Principal Investigator: Barbro Eriksson, MD PhD Akademiska Sjukhuset, Uppsala

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Responsible Party: Barbro Eriksson, Professor, Senior Attending, Uppsala University
ClinicalTrials.gov Identifier: NCT03130205     History of Changes
Other Study ID Numbers: Uppsala University Hospital
First Posted: April 26, 2017    Key Record Dates
Last Update Posted: August 25, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Neoplasms, Glandular and Epithelial
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Adenoma, Islet Cell
Adenoma
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases