Somatuline Predictive Factors in Acromegaly and NET
SOPRANo
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)
1 other identifier
observational
156
3 countries
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2012
Longer than P75 for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2012
CompletedFirst Submitted
Initial submission to the registry
April 23, 2013
CompletedFirst Posted
Study publicly available on registry
April 25, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2017
CompletedJanuary 14, 2019
January 1, 2019
4.1 years
April 23, 2013
January 11, 2019
Conditions
Outcome Measures
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)
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)
Baseline and 2 years
Study Arms (2)
Neuroendocrine Tumours
The subject will receive treatment as prescribed by the investigator and in accordance with the current recommendations, routine practice and local regulations.
Acromegaly
The subject will receive treatment as prescribed by the investigator and in accordance with the current recommendations, routine practice and local regulations.
Interventions
Eligibility Criteria
Clinics and private practitioners who treat acromegaly and/or NET subjects with Somatuline Autogel® 60, 90 or 120 mg.
You may qualify if:
- 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
You may not qualify if:
- The subject has already been included in this study
- Participation in an interventional trial
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ipsenlead
Study Sites (3)
University Hospital of Vienna
Vienna, Austria
ENDOC
Hamburg, Germany
University Hospital Basel
Basel, Switzerland
Related Publications (1)
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.
PMID: 34293802DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ipsen Medical Director
Ipsen
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 23, 2013
First Posted
April 25, 2013
Study Start
June 1, 2012
Primary Completion
July 1, 2016
Study Completion
May 1, 2017
Last Updated
January 14, 2019
Record last verified: 2019-01