Validation Study of the SAGIT® Instrument in Acromegaly

Completed

• Conditions: Acromegaly

• Registration Number: NCT02539927
• Lead Sponsor: Ipsen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-07
• Study First Submitted: 2015-07-07
• Study First Submitted QC: 2015-08-31
• Study First Posted: 2015-09-03
• Primary Completion: 2018-09-03
• Study Completion: 2018-09-03
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-31
• Last Update Posted: 2018-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 227

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Define and validate the scoring of the SAGIT® instrument	baseline	Evaluating the ability of the instrument to discriminate subgroups of subjects with acromegaly (controlled vs not controlled).

Secondary Outcome Measures

Name	Time	Method
The ability of the SAGIT® instrument to predict the occurrence of significant clinical event(s) and/or treatment change(s) over time.	2 years	Significant clinical event is defined as death, stroke, onset of diabetes, onset of arthritis/onset of arthritis disability, myocardial infarction and/or diagnosis of other tumor; treatment change is defined as change in therapeutic doses, in therapeutic drug class, surgery or radiotherapy.
Define SAGIT® characteristics for different groups	2 years	Controlled vs. non controlled. Treatment-naïve, patients vs. currently treated vs. previously treated patients
The association between the SAGIT® tool and patients' quality of life measured using Acromegaly Quality of Life (AcroQoL) scores.	2 years	Acromegaly Quality of Life (AcroQoL) scores will be compared between patient groups defined according to SAGIT scoring algorithm (controlled vs. not controlled). This comparison will be performed using t-tests for each available visit of the prospective population.

Trial Locations

Locations (28)

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

University Hospital; 🇬🇧 Cambridge, United Kingdom

Hopital Neuro-Cardiologique; 🇫🇷 Bron, France

Hopital de Bicêtre; 🇫🇷 Le Kremlin-Bicêtre, France

CHU Larrey; 🇫🇷 Toulouse, France

CHU de Marseille - Hôpital de la Timone; 🇫🇷 Marseille, France

Private Clinique; 🇩🇪 Oldenburg, Germany

Ospedaliera Spedali Civili di Brescia; 🇮🇹 Montichiari, Italy

Endoc Zentrum Fûr Endokrine Tumoren; 🇩🇪 Hamburg, Germany

Radbound UMC; 🇳🇱 Nijmegen, Netherlands

Erasmus MC; 🇳🇱 Rotterdam, Netherlands

Hospital de Condia(CHUS) RVA Ramon Baltar S/N; 🇪🇸 Santiago de Compostela, Spain

University Hospital Virgen del Rocio; 🇪🇸 Sevilla, Spain

Université Hospital; 🇬🇧 Cardiff, United Kingdom

Aberdeen Royal Infirmary; 🇬🇧 Aberdeen, United Kingdom

Endocrinology and Metabolism Churchill Hospital; 🇬🇧 Oxford, United Kingdom

Department of Clinical Medicine - The Department of Endocrinology and Diabetes; 🇩🇰 Aarhus C, Denmark

University Hospital, Dept of Endocrinology; 🇩🇰 Copenhagen, Denmark

Azienda Ospedaliero Universitar a Fedderico II; 🇮🇹 Naples, Italy

Azienda Ospedaliero Universitaria Pisana-Endcrinologia 2; 🇮🇹 Pisa, Italy

Azienda Ospedaliera di Padova; 🇮🇹 Padova, Italy

Endocrinology, University Hospital, Policlinica Gemelu; 🇮🇹 Rome, Italy

Federal University of Rio de Janeiro; 🇧🇷 Rio de Janeiro, Brazil

CHU de Liège; 🇧🇪 Liège, Belgium

LUMC Leiden,; 🇳🇱 Leiden, Netherlands