Validation Study of the SAGIT® Instrument in Acromegaly

Acromegaly Clinical Trial

— SAGIT  

Official title:

International Multicentre Validation Study of SAGIT® Instrument in Acromegaly

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02539927
• Other study ID #: 8-79-52030-295
• Status: Completed
• Start date: July 2015
• Est. completion date: September 3, 2018

Study information

• Verified date: October 2018
• Source: Ipsen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 227
• Est. completion date: September 3, 2018
• Est. primary completion date: September 3, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acromegaly

Locations

Country	Name	City	State
Belgium	CHU de Liège	Liège
Brazil	Federal University of Rio de Janeiro	Rio de Janeiro
Brazil	University Hospital	Sao Paulo
Brazil	University Hospital	São Paulo
Denmark	Department of Clinical Medicine - The Department of Endocrinology and Diabetes	Aarhus C
Denmark	University Hospital, Dept of Endocrinology	Copenhagen
France	Hopital Neuro-Cardiologique	Bron
France	Hopital de Bicêtre	Le Kremlin-Bicêtre
France	CHU de Marseille - Hôpital de la Timone	Marseille
France	CHU Larrey	Toulouse
Germany	University Hospital	Essen
Germany	Endoc Zentrum Fûr Endokrine Tumoren	Hamburg
Germany	Private Clinique	Oldenburg
Italy	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
Netherlands	LUMC Leiden,	Leiden
Netherlands	Radbound UMC	Nijmegen
Netherlands	Erasmus MC	Rotterdam
Spain	University Hospital	Barcelona
Spain	University Hospital	Madrid
Spain	Hospital de Condia(CHUS) RVA Ramon Baltar S/N	Santiago de Compostela
Spain	University Hospital Virgen del Rocio	Sevilla
United Kingdom	Aberdeen Royal Infirmary	Aberdeen
United Kingdom	University Hospital	Cambridge
United Kingdom	Université Hospital	Cardiff
United Kingdom	Endocrinology and Metabolism Churchill Hospital	Oxford
United States	The Emory Pituitary Center	Atlanta	Georgia
United States	Cleveland Clinic	Cleveland	Ohio
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	Endocrinology and Metabolism	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Ipsen

Countries where clinical trial is conducted

United States,  Belgium,  Brazil,  Denmark,  France,  Germany,  Italy,  Netherlands,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Define and validate the scoring of the SAGIT® instrument	Evaluating the ability of the instrument to discriminate subgroups of subjects with acromegaly (controlled vs not controlled).	baseline
Secondary	The ability of the SAGIT® instrument to predict the occurrence of significant clinical event(s) and/or treatment change(s) over time.	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.	2 years
Secondary	Define SAGIT® characteristics for different groups	Controlled vs. non controlled. Treatment-naïve, patients vs. currently treated vs. previously treated patients	2 years
Secondary	The association between the SAGIT® tool and patients' quality of life measured using Acromegaly Quality of Life (AcroQoL) scores.	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.	2 years