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CompletedNCT02788565STREETUpdated Jun 2, 2020

Quality of Life, Treatment Experience and Cost of Treatment With Somatostatin Analogues in Patients With Gastroenteropancreatic Neuroendocrine Tumours

An observational study in Gastroenteropancreatic Neuroendocrine Tumours, sponsored by Ipsen. Completed at 2 sites in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-06-02.

Sponsored by Ipsen · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
156
Ages
18 Years and older
Sex
All
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Study 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. 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.

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Conditions studied

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In context

Neuroendocrine Tumors

676 studies on the registry are indexed under Neuroendocrine Tumors; 169 are open to participants now.

This study's enrollment of 156 is above the median of 115 across 176 observational studies indexed under Neuroendocrine Tumors.

Browse Neuroendocrine Tumors studies →

Lead sponsor

Ipsen is the lead sponsor of 282 studies on the registry; 16 are open to participants now.

Of its 24 completed or terminated interventional studies of FDA-regulated products, 19 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Treatment clinic

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

Exclusion Criteria:

  • No specific exclusion criteria defined
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Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
156 participants (actual)
Patient registry
No
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What researchers measure

Primary outcomes

  1. 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'.

    Time frame: Day 1

Secondary outcomes

  1. 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

    Time frame: Day 1

  2. Quality of life, mean mental health score in SF-12 derived according to the SF-12 manual.

    Time frame: Day 1

  3. 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?"

    Time frame: Day 1

  4. Mean number of packs of H01CB03 and H01CB02 purchased.

    Time frame: Retrospective data collection of a 1 year period

  5. Median number of packs of H01CB03 and H01CB02 purchased.

    Time frame: Retrospective data collection of a 1 year period

  6. 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

  7. 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

  8. 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

  9. Median time - visits to primary care for injections; visits to treating physician at hospital; time to travel

    Time frame: Day 1

  10. Median time for giving injections of SSA in subjects, derived as the time reported in the nurse questionnaire.

    Time frame: Day 1

  11. Proportion of nurses who reported "moderately" or "very" or "very much" confidence in giving injections

    Time frame: Day 1

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Study locations

2 sites
  • Skane University Hospital
    Lund, 22241, Sweden
  • Uppsala University Hospital
    Uppsala, 75185, Sweden
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 2, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02788565
Lead sponsor
Ipsen
Responsible party
Sponsor
First posted
Jun 2, 2016
Start date
Mar 2016
Primary completion
Oct 2016
Completion
Dec 2016
Last update
Jun 2, 2020

Study contacts

Ipsen Medical Director
study director · Ipsen

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.

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