Validation Study of the SAGIT® Instrument in Acromegaly

Ipsen

Status: Completed

Conditions: Acromegaly

Study type: Observational

Funder types: Industry

Identifiers

NCT02539927

8-79-52030-295

Details and patient eligibility

About

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.

Enrollment: 227 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

227 participants in 3 patient groups

Controlled

Not controlled

Control status yet to be clarified