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Biomarker Study of Pancreatic Neuroendocrine Tumours

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03741517
Recruitment Status : Recruiting
First Posted : November 15, 2018
Last Update Posted : March 25, 2020
Information provided by (Responsible Party):
Joakim Crona, 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, DOTATOC-PET, FDG-PET and core needle biopsy with histopathological analysis (Ki67 index and tumor cell differentiation). Uptake on 68Ga-DOTATOC and 18F-FDG-PET will be correlated directly to tumor cell proliferation rate. Fraction of patients with spatial heterogeneity in DOTATOC as well as 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
Pancreatic Neuroendocrine Tumor Radiation: 18F-FDG-PET Radiation: 68Ga-DOTATOC-PET Radiation: Computed tomography Other: Core needle biopsy Other: Phlebotomy

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 4 Years
Official Title: Prospective Longitudinal Observation Trial of Clinical and Molecular Features of Pancreatic Neuroendocrine Tumours
Actual Study Start Date : January 30, 2019
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

Intervention Details:
  • Radiation: 18F-FDG-PET
    Fludeoxyglucose F18
  • Radiation: 68Ga-DOTATOC-PET
    DOTA-tyr3-Octreotide Ga68
  • Radiation: Computed tomography
    Computed tomography of thorax and abdomen with 3-phase contrast
  • Other: Core needle biopsy
    Core needle biopsy of metastatic lesions
  • Other: Phlebotomy
    Phlebotomy from peripheral vein

Primary Outcome Measures :
  1. Protocol adherence [ Time Frame: Study inclusion ]
    Defined as the proportion of patients where that following investigations are performed: Core needle biopsy, FDG-PET, DOTATOC-PET, research blood samples, pancreatic hormones and hormonal syndromes.

Other Outcome Measures:
  1. Safety of core needle biopsy: NCI Common Terminology Criteria [ Time Frame: At study inclusion and within 48 hours of the procedure ]
    Defined as a NCI Common Terminology Criteria for Adverse Events 4.03 grade 3-4 adverse event related to the procedure.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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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:   Non-Probability Sample
Study Population
Pancreatic Neuroendocrine Tumors

Inclusion Criteria:

  • Age ≥18 years
  • Informed consent
  • Pathology confirmed diagnosis of pancreatic neuroendocrine tumor WHO grade 1-3 or neuroendocrine carcinoma grade 3.

Exclusion Criteria:

  • Patient does not consent
  • 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 identifier (NCT number): NCT03741517

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Contact: Joakim Crona, MD, PhD 0046186110000

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Akademiska Sjukhuset Recruiting
Uppsala, Sweden, 75185
Contact: Joakim Crona, MD PhD    +46186110000   
Sponsors and Collaborators
Uppsala University
Additional Information:

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Responsible Party: Joakim Crona, Associate Professor, Uppsala University Identifier: NCT03741517    
Other Study ID Numbers: PRORESS pancreas
First Posted: November 15, 2018    Key Record Dates
Last Update Posted: March 25, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Neuroendocrine Tumors
Adenoma, Islet Cell
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Neoplasms, Glandular and Epithelial
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Fluorodeoxyglucose F18
Molecular Mechanisms of Pharmacological Action