Acromegaly
Conditions
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.
Interventions
OTHERSAGIT
SAGIT is a Clinician-Reported Outcomes (ClinROs) tool
Sponsors
Ipsen
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of acromegaly patients classified using SAGIT | 8 months |
Countries
Brazil, France, Germany, Italy, Spain, United Kingdom, United States
Outcome results
None listed