SAGIT for Classification of Patients With Acromegaly in Clinical Practice

Completed

• Conditions: Acromegaly
• Interventions: Other: SAGIT

• Registration Number: NCT02231593
• Lead Sponsor: Ipsen

Brief Summary

The purpose of this pilot study is to test SAGIT (Signs and symptoms - Associated comorbidities - GH concentration level - IGF-1 - Tumour). SAGIT is a Clinician-Reported Outcomes (ClinROs) tool developed to describe patients with acromegaly. This study will determine the potential use of a finalised operational version for patient classification in clinical practice and studies.

In addition, this study intends to carry out a qualitative evaluation of the acceptability of SAGIT by the practicing endocrinologist in terms of relevance, ease of use, applicability and usefulness of the tool in practice.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-02
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Study First Submitted: 2014-09-02
• Study First Submitted QC: 2014-09-02
• Study First Posted: 2014-09-04
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-30
• Last Update Posted: 2020-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 71

Inclusion Criteria

• Male or female aged 18 years-old or above
• Patient with diagnosis of acromegaly with the presence of pituitary adenoma, elevated IGF-1 and lack of serum GH suppression after oral glucose tolerance test (OGTT)
• Controlled/stable, active and treatment naïve patients.
• Patient with the cognitive and linguistic capacities to understand the information letter of the study
• Patient who signed informed consent

Exclusion Criteria

• History of non-compliance or inability to reliably receive treatment in the foreseeable future
• Gaps in treatment of greater than 1 month within the 12 months prior to study entry

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Acromegalic patients	SAGIT	-

Primary Outcome Measures

Name	Time	Method
Number of acromegaly patients classified using SAGIT	8 months

Trial Locations

Locations (20)

CHU Bicetre; 🇫🇷 Le Kremlin-Bicêtre, France

Federal University of Minas Gerais; 🇧🇷 Belo Horizonte, Brazil

Private practice; 🇧🇷 Saúde, Brazil

Praxisgemeinschaft an der Kaisereiche, Wilhelm-Hauff-Straße 21; 🇩🇪 Berlin, Germany

NW Pituitary Center and Neurological Surgery; 🇺🇸 Portland, Oregon, United States

CHU Rennes Hôpital sud; 🇫🇷 Rennes, France

Hôpital Huriez, CHRU DE Lille; 🇫🇷 Lille, France

Cedars-Sinai Medical Center; 🇺🇸 Los Angeles, California, United States

Leeds General Infirmary; 🇬🇧 Leeds, United Kingdom

Universitätsklinikum Hamburg-Eppendorf; 🇩🇪 Hamburg, Germany

Universitary Hospital Virgen de la Vitoria; 🇪🇸 Málaga, Spain

University of São Paulo Medical School; 🇧🇷 São Paulo, Brazil

Aberdeen Royal Infirmary; 🇬🇧 Aberdeen, United Kingdom

Montichiari Hospital; 🇮🇹 Montichiari, Italy

Hospital Universitario La Coruna; 🇪🇸 La Coruna, Spain

Azienda Ospedaliera Città della Salute e della Scienza; 🇮🇹 Torino, Italy

Derriford Hospital; 🇬🇧 Plymouth, United Kingdom

Azienda Ospedaliera Spedali Civil di Brescia; 🇮🇹 Brescia, Italy

San Giovanni Battista Hospital; 🇮🇹 Torino, Italy

LMU München; 🇩🇪 München, Germany