Gastroenteropancreatic Neuroendocrine TumoursSTREETNCT02788565
Quality of Life, Treatment Experience and Cost of Treatment With Somatostatin Analogues in Patients With Gastroenteropancreatic Neuroendocrine Tumours
An observational study of Gastroenteropancreatic Neuroendocrine Tumours, run by Ipsen at 2 sites in Sweden.
Trial summary
Data from this study will contribute additional knowledge regarding patient outcomes and direct somatostatin analogue (SSA) treatment related costs in clinical practice in the Nordic countries. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastroenteropancreatic Neuroendocrine Tumours
- How many people
- 156 participants
- Where
- 2 sitesSweden
- Study dates
- Mar 2016to Dec 2016
- 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: Treatment clinic
Who may be able to join
- Signed informed consent
- Diagnosed with a Gastroenteropancreatic Neuroendocrine Tumour (GEP-NET) and treated with SSA for at least three months but not more than 3 years
- GEP-NET proliferation index Ki 67 <10%
- Over 18 years of age
Who cannot join
- No specific exclusion criteria defined
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites
Skane University Hospital
Lund, 22241
Uppsala University Hospital
Uppsala, 75185
About this study
Official title: SOMATOSTATIN TREATMENT EXPERIENCE TRIAL An Observational Cross Sectional Trial Investigating Quality of Life, Treatment Experience and Direct Cost of Treatment With Somatostatin Analogues in Subjects With Gastroenteropancreatic Neuroendocrine Tumours (GEP-NETS)
Data from this study will contribute additional knowledge regarding patient outcomes and direct somatostatin analogue (SSA) treatment related costs in clinical practice in the Nordic countries. Such knowledge can be of importance in a treatment decision, decision support for development of care, follow up and training of both patients and primary care nurses.
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects with injection problems according to the subject
Subject questionnaire asks "In your opinion, how did the last injection go?", subject chooses either 'no problems' or 'problems occurred'.
Measured: Day 1
Secondary outcomes (11)
Quality of life, mean physical health score in SF-12 derived according to the SF-12 manual.
Mean physical health score and mean mental health score in SF-12 derived according to the SF-12 manual
Measured: Day 1
Quality of life, mean mental health score in SF-12 derived according to the SF-12 manual.
Measured: Day 1
Subject experience: proportion of subjects reporting "much" or "very much" anxiety in subject questionnaire.
Subjects asked "To what extent do you feel anxiety before the injection?"
Measured: Day 1
Mean number of packs of H01CB03 and H01CB02 purchased.
Measured: Retrospective data collection of a 1 year period
Median number of packs of H01CB03 and H01CB02 purchased.
Measured: Retrospective data collection of a 1 year period
Mean number of two consecutive dispensed prescriptions of H01CB03, H01CB02 within seven days during the pre-specified one-year period of retrospective data extraction.
Measured: Retrospective data collection of a 1 year period
Median number of two consecutive dispensed prescriptions of H01CB03, H01CB02 within seven days during the pre-specified one-year period of retrospective data extraction.
Measured: Retrospective data collection of a 1 year period
Median frequency of visits to treating physician in hospital will be derived as number of (frequency) of revisits recorded in the subject questionnaire.
Measured: Day 1
Median time - visits to primary care for injections; visits to treating physician at hospital; time to travel
Measured: Day 1
Median time for giving injections of SSA in subjects, derived as the time reported in the nurse questionnaire.
Measured: Day 1
Proportion of nurses who reported "moderately" or "very" or "very much" confidence in giving injections
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2016 (estimated)
- Study startMar 2016
- Primary completionOct 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroenteropancreatic Neuroendocrine TumoursStudies of the same condition, open and under way.
- More trials run by IpsenThe 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
- Cross-sectional
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ipsen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ipsen Medical Director, Study director, Ipsen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02788565
- Sponsor's protocol ID
- A-SE-52030-353
- Acronym
- STREET
- Status last verified
- Jun 2020
- First submitted
- 27 May 2016
- Last updated
- 2 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SOMATOSTATIN TREATMENT EXPERIENCE TRIAL An Observational Cross Sectional Trial Investigating Quality of Life, Treatment Experience and Direct Cost of Treatment With Somatostatin Analogues in Subjects With Gastroenteropancreatic Neuroendocrine Tumours (GEP-NETS)
- ClinicalTrials.gov ID
- NCT02788565
- Acronym / sponsor ID
- STREET / A-SE-52030-353
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- IpsenIndustry (pharma, biotech, devices)
- Study start
- Mar 2016
- Primary completion
- Oct 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 2 Jun 2016 (estimated)
- 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.
Data from this study will contribute additional knowledge regarding patient outcomes and direct somatostatin analogue (SSA) treatment related costs in clinical practice in the Nordic countries. Such knowledge can be of importance in a treatment decision, decision support for development of care, follow up and training of both patients and primary care nurses.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Treatment clinic
Key inclusion criteria (4 listed)
- Signed informed consent
- Diagnosed with a Gastroenteropancreatic Neuroendocrine Tumour (GEP-NET) and treated with SSA for at least three months but not more than 3 years
- GEP-NET proliferation index Ki 67 <10%
- Over 18 years of age
Key exclusion criteria (1 listed)
- No specific exclusion criteria defined
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proportion of subjects with injection problems according to the subject
Time frame: Day 1
Subject questionnaire asks "In your opinion, how did the last injection go?", subject chooses either 'no problems' or 'problems occurred'.
11 secondary outcomes
Quality of life, mean physical health score in SF-12 derived according to the SF-12 manual.
Time frame: Day 1
Quality of life, mean mental health score in SF-12 derived according to the SF-12 manual.
Time frame: Day 1
Subject experience: proportion of subjects reporting "much" or "very much" anxiety in subject questionnaire.
Time frame: Day 1
Mean number of packs of H01CB03 and H01CB02 purchased.
Time frame: Retrospective data collection of a 1 year period
Median number of packs of H01CB03 and H01CB02 purchased.
Time frame: Retrospective data collection of a 1 year period
Mean number of two consecutive dispensed prescriptions of H01CB03, H01CB02 within seven days during the pre-specified one-year period of retrospective data extraction.
Time frame: Retrospective data collection of a 1 year period
Median number of two consecutive dispensed prescriptions of H01CB03, H01CB02 within seven days during the pre-specified one-year period of retrospective data extraction.
Time frame: Retrospective data collection of a 1 year period
Median frequency of visits to treating physician in hospital will be derived as number of (frequency) of revisits recorded in the subject questionnaire.
Time frame: Day 1
Median time - visits to primary care for injections; visits to treating physician at hospital; time to travel
Time frame: Day 1
Median time for giving injections of SSA in subjects, derived as the time reported in the nurse questionnaire.
Time frame: Day 1
Proportion of nurses who reported "moderately" or "very" or "very much" confidence in giving injections
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2020.
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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.
Ipsen Medical Director study director
Ipsen
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastroenteropancreatic Neuroendocrine Tumours, run by Ipsen at 2 sites 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 4 inclusion and 1 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: finished, as of the sponsor's last update on 2 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of subjects with injection problems according to the subject (time frame: Day 1). 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 2 Jun 2020.