Validation Study of the SAGIT® Instrument in Acromegaly

Completed

Conditions studied: Acromegaly

In brief

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.

Key facts

Study ID

NCT02539927

Run by

Ipsen

People needed

227

Starts

2015-07-01

Expected to finish

2018-09-03

Last updated by the study team

2018-11-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• Acute uncontrolled disease requiring intensive care

Where it is running

• Cedars-Sinai Medical Center — Los Angeles, California, United States
• The Emory Pituitary Center — Atlanta, Georgia, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Endocrinology and Metabolism — Pittsburgh, Pennsylvania, United States
• CHU de Liège — Liège, Belgium
• Federal University of Rio de Janeiro — Rio de Janeiro, Brazil
• University Hospital — São Paulo, Brazil
• University Hospital — São Paulo, Brazil
• Department of Clinical Medicine - The Department of Endocrinology and Diabetes — Aarhus C, Denmark
• University Hospital, Dept of Endocrinology — Copenhagen, Denmark
• Hopital Neuro-Cardiologique — Bron, France
• Hopital de Bicêtre — Le Kremlin-Bicêtre, France
• CHU de Marseille - Hôpital de la Timone — Marseille, France
• CHU Larrey — Toulouse, France
• University Hospital — Essen, Germany
• Endoc Zentrum Fûr Endokrine Tumoren — Hamburg, Germany
• Private Clinique — Oldenburg, Germany
• Ospedaliera Spedali Civili di Brescia — Montichiari, Italy
• Azienda Ospedaliero Universitar a Fedderico II — Naples, Italy
• Azienda Ospedaliera di Padova — Padova, Italy
• Azienda Ospedaliero Universitaria Pisana-Endcrinologia 2 — Pisa, Italy
• Endocrinology, University Hospital, Policlinica Gemelu — Rome, Italy
• LUMC Leiden, — Leiden, Netherlands
• Radbound UMC — Nijmegen, Netherlands
• Erasmus MC — Rotterdam, Netherlands

Full record on ClinicalTrials.gov

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