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CompletedNCT01840449SOPRANoUpdated Jan 14, 2019

Somatuline Predictive Factors in Acromegaly and NET

An observational study in Acromegaly and Neuroendocrine Tumours, sponsored by Ipsen. Completed at 3 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-01-14.

Sponsored by Ipsen · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
156
Ages
18 Years and older
Sex
All
01

Study summary

The aim of the study is to identify predictive factors for the response to Lanreotide treatment in Acromegaly as well as in Neuroendocrine Tumours.

02

Conditions studied

  • Acromegaly
  • Neuroendocrine Tumours
03

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.

04

Who can participate

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

Study population

Clinics and private practitioners who treat acromegaly and/or NET subjects with Somatuline Autogel® 60, 90 or 120 mg.

Inclusion criteria

  • Written informed consent (also mandatory in case of retrospective documentation of subject data)
  • Diagnosis of acromegaly or NET with the intention to be treated with ATG or already on treatment with ATG

Exclusion criteria

Exclusion Criteria:

  • The subject has already been included in this study
  • Participation in an interventional trial
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
156 participants (actual)
Patient registry
No

Groups and cohorts

  • Neuroendocrine Tumours

    The subject will receive treatment as prescribed by the investigator and in accordance with the current recommendations, routine practice and local regulations.

    Drug: Somatuline Autogel® 60, 90 or 120 mg

  • Acromegaly

    The subject will receive treatment as prescribed by the investigator and in accordance with the current recommendations, routine practice and local regulations.

    Drug: Somatuline Autogel® 60, 90 or 120 mg

Interventions

  • DrugSomatuline Autogel® 60, 90 or 120 mg
06

What researchers measure

Primary outcomes

  1. Change in biochemical markers (Growth Hormone [GH] & Insulin-like Growth Factor 1 [IGF-1] in acromegaly subjects and Chromogranin A [CgA] in NET subjects)

    Time frame: Baseline and 1 year

Secondary outcomes

  1. Change in biochemical markers (Growth Hormone [GH] & Insulin-like Growth Factor 1 [IGF-1] in acromegaly subjects and Chromogranin A [CgA] in NET subjects)

    Time frame: Baseline and 2 years

07

Study locations

3 sites
  • University Hospital of Vienna
    Vienna, Austria
  • ENDOC
    Hamburg, Germany
  • University Hospital Basel
    Basel, Switzerland
08

References and documents

Publications

  • Rinke A, Maintz C, Muller L, Weber MM, Lahner H, Pavel M, Saeger W, Houchard A, Ungewiss H, Petersenn S. Multicenter, Observational Study of Lanreotide Autogel for the Treatment of Patients with Neuroendocrine Tumors in Routine Clinical Practice in Germany and Austria. Exp Clin Endocrinol Diabetes. 2021 Jul;129(7):500-509. doi: 10.1055/a-1342-2755. Epub 2021 Jul 22. PubMed 34293802 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 14, 2019, 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
NCT01840449
Lead sponsor
Ipsen
Responsible party
Sponsor
First posted
Apr 25, 2013
Start date
Jun 2012
Primary completion
Jul 2016
Completion
May 2017
Last update
Jan 14, 2019

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 Jan 2019. You cannot join it, but the record below documents what was studied.

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