Neuroendocrine TumorsPROGRESSNCT03130205
Biomarker Study in Pancreatic Neuroendocrine Tumours
An observational study of Neuroendocrine Tumors, run by Uppsala University at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuroendocrine Tumors
- What is being tested?
- Core Needle Biopsy, Computed Tomography and 18F-FDG-PET
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteSweden
- Study dates
- 1 May 2017to 1 Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with non-resectable metastatic pancreatic neuroendocrine tumors at the Department of Endocrine Oncology, Uppsala, Sweden.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Akademiska Sjukhuset
Uppsala, 75185
Barbro Eriksson, MD PhD, +46186110000, barbro.eriksson@medsci.uu.se
Joakim Crona, MD PhD, +46186118630, joakim.crona@medsci.uu.se
About this study
Official title: 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.
- Conditions
- Neuroendocrine Tumors
- Being tested
- Core Needle Biopsy, Computed Tomography, 18F-FDG-PET, Phlebotomy, Molecular genetic analysis
- Medical subject headings
- Neuroendocrine Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Core Needle BiopsyProcedure or surgery
Core Needle Biopsy is performed from liver metastasis.
Computed TomographyRadiation
Computed Tomography
18F-FDG-PETRadiation
18F Fluorodeoxyglucose Positron emission tomography
PhlebotomyProcedure or surgery
3 EDTA tubes drawn from peripheral vein
Molecular genetic analysisGenetic
Performed on biomaterial from peripheral vein and core needle biopsy
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between FDG-PET and tumor biology
18F-FDG-PET SUVmax correlation to Ki67 index (determined as percentage of tumor cells with positive Ki67 imunohistochemical staining).
Measured: Through study completion, an average of 3 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2017
- Study start1 May 2017
- Primary completion1 Jan 2021 (estimated)
- Study completion1 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuroendocrine TumorsStudies of the same condition, open and under way.
- More trials run by Uppsala UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Barbro Eriksson, Uppsala University
- Investigators
- Barbro Eriksson, MD PhD, Principal investigator, Akademiska Sjukhuset, Uppsala
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03130205
- Sponsor's protocol ID
- Uppsala University Hospital
- Acronym
- PROGRESS
- Status last verified
- Aug 2017
- First submitted
- 6 Apr 2017
- Last updated
- 25 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Longitudinal Biomarker Study in Pancreatic Neuroendocrine Tumours
- ClinicalTrials.gov ID
- NCT03130205
- Acronym / sponsor ID
- PROGRESS / Uppsala University Hospital
- Conditions
- Neuroendocrine Tumors
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 1 Jan 2021 (estimated)
- Study completion
- 1 Jan 2022 (estimated)
- First posted
- 26 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with non-resectable metastatic pancreatic neuroendocrine tumors at the Department of Endocrine Oncology, Uppsala, Sweden.
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (5 listed)
- Patient does not consent
- Permanent risk factors for biopsy
- Pregnancy or no contraceptive in fertile women.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Core Needle BiopsyCore Needle Biopsy is performed from liver metastasis. | Procedure or surgery | – |
| Computed TomographyComputed Tomography | Radiation | – |
| 18F-FDG-PET18F Fluorodeoxyglucose Positron emission tomography | Radiation | – |
| Phlebotomy3 EDTA tubes drawn from peripheral vein | Procedure or surgery | – |
| Molecular genetic analysisPerformed on biomaterial from peripheral vein and core needle biopsy | Genetic | – |
Primary outcome
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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barbro Eriksson, MD PhD principal investigator
Akademiska Sjukhuset, Uppsala
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuroendocrine Tumors, run by Uppsala University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Barbro Eriksson, MD PhD (+46186110000, barbro.eriksson@medsci.uu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between FDG-PET and tumor biology (time frame: Through study completion, an average of 3 years.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2017.