SAGIT for Classification of Patients With Acromegaly in Clinical Practice
Completed
Conditions studied: Acromegaly
In brief
The purpose of this pilot study is to test SAGIT (Signs and symptoms - Associated comorbidities - GH concentration level - IGF-1 - Tumour). SAGIT is a Clinician-Reported Outcomes (ClinROs) tool developed to describe patients with acromegaly. This study will determine the potential use of a finalised operational version for patient classification in clinical practice and studies. In addition, this study intends to carry out a qualitative evaluation of the acceptability of SAGIT by the practicing endocrinologist in terms of relevance, ease of use, applicability and usefulness of the tool in practice.
Key facts
- Study ID
- NCT02231593
- Run by
- Ipsen
- People needed
- 71
- Starts
- 2013-02-01
- Expected to finish
- 2014-05-01
- Last updated by the study team
- 2020-03-31
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Male or female aged 18 years-old or above
- Patient with diagnosis of acromegaly with the presence of pituitary adenoma, elevated IGF-1 and lack of serum GH suppression after oral glucose tolerance test (OGTT)
- Controlled/stable, active and treatment naïve patients.
- Patient with the cognitive and linguistic capacities to understand the information letter of the study
- Patient who signed informed consent
You may not qualify if…
- History of non-compliance or inability to reliably receive treatment in the foreseeable future
- Gaps in treatment of greater than 1 month within the 12 months prior to study entry
Where it is running
- Cedars-Sinai Medical Center — Los Angeles, California, United States
- NW Pituitary Center and Neurological Surgery — Portland, Oregon, United States
- Federal University of Minas Gerais — Belo Horizonte, Brazil
- Private practice — Curitiba, Brazil
- Private practice — Saúde, Brazil
- University of São Paulo Medical School — São Paulo, Brazil
- CHU Bicetre — Le Kremlin-Bicêtre, France
- Hôpital Huriez, CHRU DE Lille — Lille, France
- CHU Rennes Hôpital sud — Rennes, France
- Praxisgemeinschaft an der Kaisereiche, Wilhelm-Hauff-Straße 21 — Berlin, Germany
- Universitätsklinikum Hamburg-Eppendorf — Hamburg, Germany
- LMU München — München, Germany
- Azienda Ospedaliera Spedali Civil di Brescia — Brescia, Italy
- Montichiari Hospital — Montichiari, Italy
- Azienda Ospedaliera Città della Salute e della Scienza — Torino, Italy
- San Giovanni Battista Hospital — Torino, Italy
- Hospital Universitario La Coruna — A Coruña, Spain
- Universitary Hospital Virgen de la Vitoria — Málaga, Spain
- Aberdeen Royal Infirmary — Aberdeen, United Kingdom
- Leeds General Infirmary — Leeds, United Kingdom
- Derriford Hospital — Plymouth, United Kingdom
Full record on ClinicalTrials.gov
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