Brief Title
Somatuline Predictive Factors in Acromegaly and NET
Official Title
Non-interventional, Observational Study to Evaluate Common Therapeutic Algorithms and Possible Predictive Parameters for Somatuline Autogel® (ATG) Treatment in Subjects With Either Acromegaly or Neuroendocrine Tumours (NET)
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.
Study Type
Observational
Primary Outcome
Change in biochemical markers (Growth Hormone [GH] & Insulin-like Growth Factor 1 [IGF-1] in acromegaly subjects and Chromogranin A [CgA] in NET subjects)
Secondary Outcome
Change in biochemical markers (Growth Hormone [GH] & Insulin-like Growth Factor 1 [IGF-1] in acromegaly subjects and Chromogranin A [CgA] in NET subjects)
Condition
Acromegaly
Intervention
Somatuline Autogel® 60, 90 or 120 mg
Study Arms / Comparison Groups
Neuroendocrine Tumours
Description: The subject will receive treatment as prescribed by the investigator and in accordance with the current recommendations, routine practice and local regulations.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
156
Start Date
June 2012
Completion Date
May 2017
Primary Completion Date
July 2016
Eligibility Criteria
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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Ipsen Medical Director, ,
Location Countries
Austria
Location Countries
Austria
Administrative Informations
NCT ID
NCT01840449
Organization ID
A-94-52030-240
Responsible Party
Sponsor
Study Sponsor
Ipsen
Study Sponsor
Ipsen Medical Director, Study Director, Ipsen
Verification Date
January 2019