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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

Tracking Information
First Submitted Date April 6, 2017
First Posted Date April 26, 2017
Last Update Posted Date August 25, 2017
Actual Study Start Date May 1, 2017
Estimated Primary Completion Date January 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 25, 2017)
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).
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03130205 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Biomarker Study in Pancreatic Neuroendocrine Tumours
Official Title Prospective Longitudinal Biomarker Study in Pancreatic Neuroendocrine Tumours
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Core needle Biopsy Phlebotomy
Sampling Method Probability Sample
Study Population Patients with non-resectable metastatic pancreatic neuroendocrine tumors at the Department of Endocrine Oncology, Uppsala, Sweden.
Condition Neuroendocrine Tumors
Intervention
  • 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
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: April 25, 2017)
30
Original Estimated Enrollment Same as current
Estimated Study Completion Date January 1, 2022
Estimated Primary Completion Date January 1, 2021   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Barbro Eriksson, MD PhD +46186110000 barbro.eriksson@medsci.uu.se
Contact: Joakim Crona, MD PhD +46186118630 joakim.crona@medsci.uu.se
Listed Location Countries Sweden
Removed Location Countries  
 
Administrative Information
NCT Number NCT03130205
Other Study ID Numbers Uppsala University Hospital
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Barbro Eriksson, Uppsala University
Study Sponsor Uppsala University
Collaborators Not Provided
Investigators
Principal Investigator: Barbro Eriksson, MD PhD Akademiska Sjukhuset, Uppsala
PRS Account Uppsala University
Verification Date August 2017