Brief Title
Validation Study of the SAGIT® Instrument in Acromegaly
Official Title
International Multicentre Validation Study of SAGIT® Instrument in Acromegaly
Brief Summary
Patients will be treated in accordance with the standard medical practice of the hospital
where they have been recruited during their participation in this study. No additional
assessments or tests will be required.
SAGIT® is a new instrument developed by a group of acromegaly experts to help practicing
endocrinologists to manage acromegalic patients and disease activity in their clinical
practice and define acromegaly staging. It reports 5 elements: Signs and symptoms - S;
Associated comorbidities - A; Growth hormone (GH) concentration - G; Insulin-like growth
factor 1(IGF-1) concentration -I; Tumour size- T.
The instrument has been pre evaluated during a qualitative pilot study. The purpose of the
validation study is to define and validate the scoring of the SAGIT® instrument.
Study Type
Observational
Primary Outcome
Define and validate the scoring of the SAGIT® instrument
Secondary Outcome
The ability of the SAGIT® instrument to predict the occurrence of significant clinical event(s) and/or treatment change(s) over time.
Condition
Acromegaly
Study Arms / Comparison Groups
Controlled
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
Estimated Enrollment
227
Start Date
July 2015
Completion Date
September 3, 2018
Primary Completion Date
September 3, 2018
Eligibility Criteria
Inclusion Criteria:
- Male or female aged 18 years-old or above at study inclusion
- Treatment-naïve and non treatment-naïve patients with a diagnosis of acromegaly
- Data required to complete the SAGIT® tool are available in the patient medical records
and do not require additional assessments or tests
- Data required to complete the SAGIT® tool are recorded within the 3 months preceding
the inclusion visit (6 months for MRI)
Exclusion Criteria:
- Acute uncontrolled disease requiring intensive care
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Ipsen Medical Director, ,
Location Countries
Belgium
Location Countries
Belgium
Administrative Informations
NCT ID
NCT02539927
Organization ID
8-79-52030-295
Responsible Party
Sponsor
Study Sponsor
Ipsen
Study Sponsor
Ipsen Medical Director, Study Director, Ipsen
Verification Date
October 2018