Clinical trial · Observational
Non Interventional Post Marketing Programme in Neuroendocrine Tumours
An Observational, Multicentre, Open Label, Non Interventional Programme to Assess the Long-Term Safety and Efficacy of Somatuline Autogel in the Treatment of Neuroendocrine Tumours When Administered by Patients or Their Partners ("Home Injection Group") or Administered by Healthcare Professionals
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study, is to assess the safety and local tolerability of the long-term use of Somatuline Autogel when administered by patients or their partners ("Home Injection Group") and the safety and local tolerability in patients receiving their injection from a healthcare professional (HCP) ("Reference Group").
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neuroendocrine Tumors | Neuroendocrine Tumor | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- safety and local tolerability of Somatuline Autogel when administered by patients or their partners or from a healthcare professional
- timeFrame
- End of observational period
Secondary outcomes (3)
- measure
- efficacy of Somatuline Autogel
- timeFrame
- End of observational period
- measure
- training requirements for patients / partners to perform home injection of Somatuline Autogel
- timeFrame
- End of observational period
- measure
- acceptability of home injections to patients, partners and healthcare professionals
- timeFrame
- End of observational period
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * The patient must give written (personally signed and dated) informed consent for their data to be included in the database for this Post Marketing Surveillance programme and any subsequent analysis. * The patient must have been receiving treatment with Somatuline Autogel at a stable dose for at least 4 months. * The patient must have a diagnosis of neuroendocrine tumours * The patient must be at least 18 years of age * For patients receiving or intending to receive Somatuline Autogel by home injection: * The patient must be able to store Somatuline Autogel safely in a refrigerator in their own home and either collect it from their GP/Pharmacy on a monthly basis, or receive the medication by a home delivery service. Exclusion Criteria: * The patient is pregnant or breast-feeding, unless continued treatment with Somatuline Autogel is clearly needed (as determined by the treating clinician).
References
Publications (0)
Data not yet available