Biomarker Study in Pancreatic Neuroendocrine Tumours (PROGRESS)

August 24, 2017 updated by: Barbro Eriksson, Uppsala University

Prospective Longitudinal Biomarker Study in Pancreatic Neuroendocrine Tumours

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with non-resectable metastatic pancreatic neuroendocrine tumors at the Department of Endocrine Oncology, Uppsala, Sweden.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Through study completion, an average of 3 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Uppsala University

Investigators

  • Principal Investigator: Barbro Eriksson, MD PhD, Akademiska sjukhuset, Uppsala

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2017

Primary Completion (Anticipated)

January 1, 2021

Study Completion (Anticipated)

January 1, 2022

Study Registration Dates

First Submitted

April 6, 2017

First Submitted That Met QC Criteria

April 25, 2017

First Posted (Actual)

April 26, 2017

Study Record Updates

Last Update Posted (Actual)

August 25, 2017

Last Update Submitted That Met QC Criteria

August 24, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Uppsala University Hospital

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Neuroendocrine Tumors

Clinical Trials on Core Needle Biopsy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Australia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe