CClinicalTrials.gg
Status unknownNCT03741517Updated May 18, 2022

Biomarker Study of Pancreatic Neuroendocrine Tumours

An observational study in Pancreatic Neuroendocrine Tumor, sponsored by Uppsala University. Status unknown at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-05-18.

Sponsored by Uppsala University · Observational

The sponsor has not verified this record recently (last verified May 2022), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
40
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Pancreatic Neuroendocrine Tumor
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In context

Neuroendocrine Tumors

676 studies on the registry are indexed under Neuroendocrine Tumors; 169 are open to participants now.

This study's planned enrollment of 40 is below the median of 115 across 176 observational studies indexed under Neuroendocrine Tumors.

Browse Neuroendocrine Tumors studies →

Lead sponsor

Uppsala University is the lead sponsor of 381 studies on the registry; 84 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

Exclusion Criteria:

  • Patient does not consent
  • Pregnancy or no contraceptive in fertile women.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
40 participants (estimated)
Target follow-up
4 Years
Patient registry
Yes

Interventions

  • Radiation18F-FDG-PET

    Fludeoxyglucose F18

  • Radiation68Ga-DOTATOC-PET

    DOTA-tyr3-Octreotide Ga68

  • RadiationComputed tomography

    Computed tomography of thorax and abdomen with 3-phase contrast

  • OtherCore needle biopsy

    Core needle biopsy of metastatic lesions

  • OtherPhlebotomy

    Phlebotomy from peripheral vein

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What researchers measure

Primary outcomes

  1. Protocol adherence

    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.

    Time frame: Study inclusion

Other outcomes

  1. Safety of core needle biopsy: NCI Common Terminology Criteria

    Defined as a NCI Common Terminology Criteria for Adverse Events 4.03 grade 3-4 adverse event related to the procedure.

    Time frame: At study inclusion and within 48 hours of the procedure

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Study locations

1 of 1 sites recruiting
  • Akademiska Sjukhuset
    Uppsala, 75185, Sweden
    Recruiting
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References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 18, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03741517
Lead sponsor
Uppsala University
Responsible party
Joakim Crona (Associate Professor, Uppsala University) — Principal investigator
First posted
Nov 15, 2018
Start date
Jan 30, 2019
Primary completion
Dec 31, 2024 (estimated)
Completion
Dec 31, 2024 (estimated)
Last update
May 18, 2022

Study contacts

Joakim Crona, MD, PhD
Contact
joakim.crona@medsci.uu.se
0046186110000

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2022. You cannot join it, but the record below documents what was studied.

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