Clinical trial NCT02231593: SAGIT for Classification of Patients With Acromegaly in Clinical Practice
Official title: Pilot Testing of SAGIT in Patients With Acromegaly in Clinical Practice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acromegaly
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2014-09-04
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Acromegaly patients registered with endocrinologists (hospital-based or outpatient clinics)

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of acromegaly patients classified using SAGIT
timeFrame: 8 months
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Portland
country: United States
facility: NW Pituitary Center and Neurological Surgery
state: Oregon
city: Belo Horizonte
country: Brazil
facility: Federal University of Minas Gerais
city: Curitiba
country: Brazil
facility: Private practice
city: Saúde
country: Brazil
facility: Private practice
city: São Paulo
country: Brazil
facility: University of São Paulo Medical School
city: Le Kremlin-Bicêtre
country: France
facility: CHU Bicetre
city: Lille
country: France
facility: Hôpital Huriez, CHRU DE Lille
city: Rennes
country: France
facility: CHU Rennes Hôpital sud
city: Berlin
country: Germany
facility: Praxisgemeinschaft an der Kaisereiche, Wilhelm-Hauff-Straße 21
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg-Eppendorf
city: München
country: Germany
facility: LMU München
city: Brescia
country: Italy
facility: Azienda Ospedaliera Spedali Civil di Brescia
city: Montichiari
country: Italy
facility: Montichiari Hospital
city: Torino
country: Italy
facility: Azienda Ospedaliera Città della Salute e della Scienza
city: Torino
country: Italy
facility: San Giovanni Battista Hospital
city: La Coruna
country: Spain
facility: Hospital Universitario La Coruna
city: Málaga
country: Spain
facility: Universitary Hospital Virgen de la Vitoria
city: Aberdeen
country: United Kingdom
facility: Aberdeen Royal Infirmary
city: Leeds
country: United Kingdom
facility: Leeds General Infirmary
city: Plymouth
country: United Kingdom
facility: Derriford Hospital
Study officials:
affiliation: Ipsen
name: Ipsen Study Director
role: STUDY_DIRECTOR
References:
citation: Giustina A, Bevan JS, Bronstein MD, Casanueva FF, Chanson P, Petersenn S, Thanh XM, Sert C, Houchard A, Guillemin I, Melmed S; SAGIT Investigator Group. SAGIT(R): clinician-reported outcome instrument for managing acromegaly in clinical practice--development and results from a pilot study. Pituitary. 2016 Feb;19(1):39-49. doi: 10.1007/s11102-015-0681-2.