Clinical trial NCT02539927: Validation Study of the SAGIT® Instrument in Acromegaly
Official title: International Multicentre Validation Study of SAGIT® Instrument in Acromegaly
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acromegaly
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2015-09-03
Enrollment: 227
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients suffering from Acromegaly in specialist care clinics and hospital clinics.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Define and validate the scoring of the SAGIT® instrument
timeFrame: baseline
Secondary outcomes:
measure: The ability of the SAGIT® instrument to predict the occurrence of significant clinical event(s) and/or treatment change(s) over time.
timeFrame: 2 years
measure: Define SAGIT® characteristics for different groups
timeFrame: 2 years
measure: The association between the SAGIT® tool and patients' quality of life measured using Acromegaly Quality of Life (AcroQoL) scores.
timeFrame: 2 years
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Atlanta
country: United States
facility: The Emory Pituitary Center
state: Georgia
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Pittsburgh
country: United States
facility: Endocrinology and Metabolism
state: Pennsylvania
city: Liège
country: Belgium
facility: CHU de Liège
city: Rio de Janeiro
country: Brazil
facility: Federal University of Rio de Janeiro
city: Sao Paulo
country: Brazil
facility: University Hospital
city: São Paulo
country: Brazil
facility: University Hospital
city: Aarhus C
country: Denmark
facility: Department of Clinical Medicine - The Department of Endocrinology and Diabetes
city: Copenhagen
country: Denmark
facility: University Hospital, Dept of Endocrinology
city: Bron
country: France
facility: Hopital Neuro-Cardiologique
city: Le Kremlin-Bicêtre
country: France
facility: Hopital de Bicêtre
city: Marseille
country: France
facility: CHU de Marseille - Hôpital de la Timone
city: Toulouse
country: France
facility: CHU Larrey
city: Essen
country: Germany
facility: University Hospital
city: Hamburg
country: Germany
facility: Endoc Zentrum Fûr Endokrine Tumoren
city: Oldenburg
country: Germany
facility: Private Clinique
city: Montichiari
country: Italy
facility: Ospedaliera Spedali Civili di Brescia
city: Naples
country: Italy
facility: Azienda Ospedaliero Universitar a Fedderico II
city: Padova
country: Italy
facility: Azienda Ospedaliera di Padova
city: Pisa
country: Italy
facility: Azienda Ospedaliero Universitaria Pisana-Endcrinologia 2
city: Rome
country: Italy
facility: Endocrinology, University Hospital, Policlinica Gemelu
city: Leiden
country: Netherlands
facility: LUMC Leiden,
city: Nijmegen
country: Netherlands
facility: Radbound UMC
city: Rotterdam
country: Netherlands
facility: Erasmus MC
city: Barcelona
country: Spain
facility: University Hospital
city: Madrid
country: Spain
facility: University Hospital
city: Santiago de Compostela
country: Spain
facility: Hospital de Condia(CHUS) RVA Ramon Baltar S/N
city: Sevilla
country: Spain
facility: University Hospital Virgen del Rocio
city: Aberdeen
country: United Kingdom
facility: Aberdeen Royal Infirmary
city: Cambridge
country: United Kingdom
facility: University Hospital
city: Cardiff
country: United Kingdom
facility: Université Hospital
city: Oxford
country: United Kingdom
facility: Endocrinology and Metabolism Churchill Hospital
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References:
citation: Giustina A, Bronstein MD, Chanson P, Petersenn S, Casanueva FF, Sert C, Houchard A, Melmed S. International Multicenter Validation Study of the SAGIT(R) Instrument in Acromegaly. J Clin Endocrinol Metab. 2021 Nov 19;106(12):3555-3568. doi: 10.1210/clinem/dgab536.
citation: Giustina A, Bronstein MD, Chanson P, Petersenn S, Casanueva FF, Sert C, Houchard A, Melmed S. Staging and managing patients with acromegaly in clinical practice: baseline data from the SAGIT(R) validation study. Pituitary. 2019 Oct;22(5):476-487. doi: 10.1007/s11102-019-00977-5.