Biomarker Study of Pancreatic Neuroendocrine Tumours

Pancreatic Neuroendocrine Tumor Clinical Trial

Official title:

Prospective Longitudinal Observation Trial of Clinical and Molecular Features of Pancreatic Neuroendocrine Tumours

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03741517
• Other study ID #: PRORESS pancreas
• Status: Recruiting
• Start date: January 30, 2019
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2022
• Source: Uppsala University
• Contact: Joakim Crona, MD, PhD
• Phone: 0046186110000
• Email: joakim.crona[@]medsci.uu.se
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Neuroendocrine Tumors
• Pancreatic Neuroendocrine Tumor

Intervention

Radiation:
• 18F-FDG-PET
Fludeoxyglucose F18
• 68Ga-DOTATOC-PET
DOTA-tyr3-Octreotide Ga68
• Computed tomography
Computed tomography of thorax and abdomen with 3-phase contrast

Other:
• Core needle biopsy
Core needle biopsy of metastatic lesions
• Phlebotomy
Phlebotomy from peripheral vein

Locations

Country	Name	City	State
Sweden	Akademiska Sjukhuset	Uppsala

Sponsors (1)

Lead Sponsor	Collaborator
Uppsala University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	At study inclusion and within 48 hours of the procedure
Primary	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.	Study inclusion