Somatuline Predictive Factors in Acromegaly and NET

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

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Key information

Conditions

Acromegaly Bone Diseases Bone Diseases, Endocrine Brain Diseases Central Nervous System Diseases Endocrine System Diseases Hyperpituitarism Hypothalamic Diseases Musculoskeletal Diseases Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Nervous System Diseases Neuroectodermal Tumors Neuroendocrine Tumors Neuroendocrine Tumours Pituitary Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital of Vienna, Vienna, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Somatuline Autogel® 60, 90 or 120 mg

Drug

Primary outcomes

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

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

Sponsors and collaborators

Lead sponsor

Ipsen

Industry

Registry information

Official study 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)

Acronym: SOPRANo

Important dates

Study start: 2012
Primary completion: 2016
Study completion: 2017
First posted: Apr 25, 2013
Registry last updated: Jan 14, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed