Gastroenteropancreatic Neuroendocrine Tumours Clinical Trial
— STREETOfficial 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)
| NCT number | NCT02788565 |
| Other study ID # | A-SE-52030-353 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | March 2016 |
| Est. completion date | December 2016 |
| Verified date | June 2020 |
| Source | Ipsen |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 156 |
| Est. completion date | December 2016 |
| Est. primary completion date | October 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - No specific exclusion criteria defined |
| Country | Name | City | State |
|---|---|---|---|
| Sweden | Skane University Hospital | Lund | |
| Sweden | Uppsala University Hospital | Uppsala |
| Lead Sponsor | Collaborator |
|---|---|
| Ipsen |
Sweden,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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'. | Day 1 | |
| Secondary | 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 | Day 1 | |
| Secondary | Quality of life, mean mental health score in SF-12 derived according to the SF-12 manual. | Day 1 | ||
| Secondary | 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?" | Day 1 | |
| Secondary | Mean number of packs of H01CB03 and H01CB02 purchased. | Retrospective data collection of a 1 year period | ||
| Secondary | Median number of packs of H01CB03 and H01CB02 purchased. | Retrospective data collection of a 1 year period | ||
| Secondary | Mean number of two consecutive dispensed prescriptions of H01CB03, H01CB02 within seven days during the pre-specified one-year period of retrospective data extraction. | Retrospective data collection of a 1 year period | ||
| Secondary | Median number of two consecutive dispensed prescriptions of H01CB03, H01CB02 within seven days during the pre-specified one-year period of retrospective data extraction. | Retrospective data collection of a 1 year period | ||
| Secondary | Median frequency of visits to treating physician in hospital will be derived as number of (frequency) of revisits recorded in the subject questionnaire. | Day 1 | ||
| Secondary | Median time - visits to primary care for injections; visits to treating physician at hospital; time to travel | Day 1 | ||
| Secondary | Median time for giving injections of SSA in subjects, derived as the time reported in the nurse questionnaire. | Day 1 | ||
| Secondary | Proportion of nurses who reported "moderately" or "very" or "very much" confidence in giving injections | Day 1 |