Brief Title
SAGIT for Classification of Patients With Acromegaly in Clinical Practice
Official Title
Pilot Testing of SAGIT in Patients With Acromegaly in Clinical Practice
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.
Study Type
Observational
Primary Outcome
Number of acromegaly patients classified using SAGIT
Condition
Acromegaly
Intervention
SAGIT
Study Arms / Comparison Groups
Acromegalic patients
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Estimated Enrollment
71
Start Date
February 2013
Completion Date
May 2014
Primary Completion Date
May 2014
Eligibility Criteria
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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Ipsen Study Director, ,
Location Countries
Brazil
Location Countries
Brazil
Administrative Informations
NCT ID
NCT02231593
Organization ID
8-79-52030-257
Responsible Party
Sponsor
Study Sponsor
Ipsen
Study Sponsor
Ipsen Study Director, Study Director, Ipsen
Verification Date
March 2020