Somatuline Predictive Factors in Acromegaly and NET

Completed

• Conditions: Acromegaly; Neuroendocrine Tumours
• Interventions: Drug: Somatuline Autogel® 60, 90 or 120 mg

• Registration Number: NCT01840449
• Lead Sponsor: Ipsen

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2013-04-23
• Study First Submitted QC: 2013-04-23
• Study First Posted: 2013-04-25
• Primary Completion: 2016-07
• Study Completion: 2017-05
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-11
• Last Update Posted: 2019-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 156

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

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Neuroendocrine Tumours	Somatuline Autogel® 60, 90 or 120 mg	The subject will receive treatment as prescribed by the investigator and in accordance with the current recommendations, routine practice and local regulations.
Acromegaly	Somatuline Autogel® 60, 90 or 120 mg	The subject will receive treatment as prescribed by the investigator and in accordance with the current recommendations, routine practice and local regulations.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change in biochemical markers (Growth Hormone [GH] & Insulin-like Growth Factor 1 [IGF-1] in acromegaly subjects and Chromogranin A [CgA] in NET subjects)	Baseline and 2 years

Trial Locations

Locations (3)

ENDOC; 🇩🇪 Hamburg, Germany

University Hospital of Vienna; 🇦🇹 Vienna, Austria

University Hospital Basel; 🇨🇭 Basel, Switzerland