Pancreatic Neuroendocrine TumorNCT03741517
Biomarker Study of Pancreatic Neuroendocrine Tumours
An observational study of Pancreatic Neuroendocrine Tumor, 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
- Pancreatic Neuroendocrine Tumor
- What is being tested?
- 18F-FDG-PET, 68Ga-DOTATOC-PET and Computed tomography
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteSweden
- Study dates
- 30 Jan 2019to 31 Dec 2024
- How long will I take part?
- 4 Years
- 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: Pancreatic Neuroendocrine Tumors
Who may be able to join
- Age ≥18 years
- Informed consent
- Pathology confirmed diagnosis of pancreatic neuroendocrine tumor WHO grade 1-3 or neuroendocrine carcinoma grade 3.
Who cannot join
- Patient does not consent
- 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
Joakim Crona, MD PhD, +46186110000, joakim.crona@medsci.uu.se
About this study
Official title: Prospective Longitudinal Observation Trial of Clinical and Molecular Features of 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, 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
- Being tested
- 18F-FDG-PET, 68Ga-DOTATOC-PET, Computed tomography, Core needle biopsy, Phlebotomy
- Medical subject headings
- Adenoma, Islet Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-FDG-PETRadiation
Fludeoxyglucose F18
68Ga-DOTATOC-PETRadiation
DOTA-tyr3-Octreotide Ga68
Computed tomographyRadiation
Computed tomography of thorax and abdomen with 3-phase contrast
Core needle biopsyOther
Core needle biopsy of metastatic lesions
PhlebotomyOther
Phlebotomy from peripheral vein
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Study inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2018
- Study start30 Jan 2019
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Neuroendocrine TumorStudies 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
- 40 participants (estimated)
- Target duration
- 4 Years
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joakim Crona, Uppsala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03741517
- Sponsor's protocol ID
- PRORESS pancreas
- Status last verified
- May 2022
- First submitted
- 9 Nov 2018
- Last updated
- 18 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Longitudinal Observation Trial of Clinical and Molecular Features of Pancreatic Neuroendocrine Tumours
- ClinicalTrials.gov ID
- NCT03741517
- Acronym / sponsor ID
- PRORESS pancreas
- Conditions
- Pancreatic Neuroendocrine Tumor
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Study start
- 30 Jan 2019 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 15 Nov 2018 (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, 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 4 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pancreatic Neuroendocrine Tumors
Key inclusion criteria (3 listed)
- Age ≥18 years
- Informed consent
- Pathology confirmed diagnosis of pancreatic neuroendocrine tumor WHO grade 1-3 or neuroendocrine carcinoma grade 3.
Key exclusion criteria (2 listed)
- Patient does not consent
- 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 |
|---|---|---|
| 18F-FDG-PETFludeoxyglucose F18 | Radiation | – |
| 68Ga-DOTATOC-PETDOTA-tyr3-Octreotide Ga68 | Radiation | – |
| Computed tomographyComputed tomography of thorax and abdomen with 3-phase contrast | Radiation | – |
| Core needle biopsyCore needle biopsy of metastatic lesions | Other | – |
| PhlebotomyPhlebotomy from peripheral vein | Other | – |
Primary outcome
Protocol adherence
Time frame: Study inclusion
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2022.
- Individual participant dataSharing planned: Yes
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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.
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 Pancreatic Neuroendocrine Tumor, 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 3 inclusion and 2 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 18 May 2022. 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 Joakim Crona, MD, PhD (0046186110000, joakim.crona@medsci.uu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Protocol adherence (time frame: Study inclusion). 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 18 May 2022.