SAGIT for Classification of Patients With Acromegaly in Clinical Practice
- Conditions
- Acromegaly
- Registration Number
- NCT02231593
- Lead Sponsor
- Ipsen
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 71
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of acromegaly patients classified using SAGIT 8 months
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (20)
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
🇧🇷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
Scroll for more (10 remaining)Cedars-Sinai Medical Center🇺🇸Los Angeles, California, United States