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Trials / Completed

CompletedNCT02539927

Validation Study of the SAGIT® Instrument in Acromegaly

International Multicentre Validation Study of SAGIT® Instrument in Acromegaly

Status
Completed
Phase
Study type
Observational
Enrollment
227 (actual)
Sponsor
Ipsen · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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

Timeline

Start date
2015-07-01
Primary completion
2018-09-03
Completion
2018-09-03
First posted
2015-09-03
Last updated
2018-11-01

Locations

33 sites across 10 countries: United States, Belgium, Brazil, Denmark, France, Germany, Italy, Netherlands, Spain, United Kingdom

Source: ClinicalTrials.gov record NCT02539927. Inclusion in this directory is not an endorsement.