Biomarker Study of Pancreatic Neuroendocrine Tumours

NCT03741517 | Unknown

• 1 other identifier: PRORESS pancreas
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Neuroendocrine Tumor

Outcome Measures

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.

  Study inclusion

Other Outcomes (1)

• Safety of core needle biopsy: NCI Common Terminology Criteria

  At study inclusion and within 48 hours of the procedure

Interventions

18F-FDG-PET RADIATION

Fludeoxyglucose F18

68Ga-DOTATOC-PET RADIATION

DOTA-tyr3-Octreotide Ga68

Computed tomography RADIATION

Computed tomography of thorax and abdomen with 3-phase contrast

Core needle biopsy OTHER

Core needle biopsy of metastatic lesions

Phlebotomy OTHER

Phlebotomy from peripheral vein

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pancreatic Neuroendocrine Tumors

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Uppsala University: lead

Study Sites (1)

Akademiska Sjukhuset

Uppsala, 75185, Sweden

RECRUITING

MeSH Terms

Conditions

Adenoma, Islet Cell

Interventions

Biopsy, Large-Core Needle; Phlebotomy

Condition Hierarchy (Ancestors)

Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Pancreatic Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biopsy, Needle; Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Punctures; Investigative Techniques; Blood Specimen Collection; Therapeutics

Central Study Contacts

Joakim Crona, MD, PhD

CONTACT

0046186110000; joakim.crona@medsci.uu.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 9, 2018
• First Posted: November 15, 2018
• Study Start: January 30, 2019
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: May 18, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share

Locations

SE (1)