Validation Study of the SAGIT® Instrument in Acromegaly
NCT02539927 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 227
Last updated 2018-11-01
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.
Conditions
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Ipsen Medical Director · Ipsen
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-07-31
- Primary Completion
- 2018-09-03
- Completion
- 2018-09-03
Countries
- United States
- Belgium
- Brazil
- Denmark
- France
- Germany
- Italy
- Netherlands
- Spain
- United Kingdom
Study Locations
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