Validation Study of the SAGIT® Instrument in Acromegaly
SAGIT
International Multicentre Validation Study of SAGIT® Instrument in Acromegaly
1 other identifier
observational
227
10 countries
33
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2015
Typical duration for all trials
33 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2015
CompletedFirst Submitted
Initial submission to the registry
July 7, 2015
CompletedFirst Posted
Study publicly available on registry
September 3, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 3, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 3, 2018
CompletedNovember 1, 2018
October 1, 2018
3.2 years
July 7, 2015
October 31, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
The ability of the SAGIT® instrument to predict the occurrence of significant clinical event(s) and/or treatment change(s) over time.
2 years
Define SAGIT® characteristics for different groups
2 years
The association between the SAGIT® tool and patients' quality of life measured using Acromegaly Quality of Life (AcroQoL) scores.
2 years
Study Arms (3)
Controlled
Not controlled
Control status yet to be clarified
Eligibility Criteria
Patients suffering from Acromegaly in specialist care clinics and hospital clinics.
You may qualify if:
- 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
You may not qualify if:
- Acute uncontrolled disease requiring intensive care
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ipsenlead
Study Sites (33)
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
The Emory Pituitary Center
Atlanta, Georgia, 30322, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Endocrinology and Metabolism
Pittsburgh, Pennsylvania, 15212, United States
CHU de Liège
Liège, Belgium
Federal University of Rio de Janeiro
Rio de Janeiro, 21941-913, Brazil
University Hospital
São Paulo, 0503900, Brazil
University Hospital
São Paulo, Brazil
Department of Clinical Medicine - The Department of Endocrinology and Diabetes
Aarhus C, 8000, Denmark
University Hospital, Dept of Endocrinology
Copenhagen, 2100, Denmark
Hopital Neuro-Cardiologique
Bron, 69677, France
Hopital de Bicêtre
Le Kremlin-Bicêtre, 94275, France
CHU de Marseille - Hôpital de la Timone
Marseille, 13385, France
CHU Larrey
Toulouse, 31400, France
University Hospital
Essen, 45147, Germany
Endoc Zentrum Fûr Endokrine Tumoren
Hamburg, 20357, Germany
Private Clinique
Oldenburg, 26122, Germany
Ospedaliera Spedali Civili di Brescia
Montichiari, 25018, Italy
Azienda Ospedaliero Universitar a Fedderico II
Naples, Italy
Azienda Ospedaliera di Padova
Padua, Italy
Azienda Ospedaliero Universitaria Pisana-Endcrinologia 2
Pisa, Italy
Endocrinology, University Hospital, Policlinica Gemelu
Rome, 00168, Italy
LUMC Leiden,
Leiden, 2333 2A, Netherlands
Radbound UMC
Nijmegen, Netherlands
Erasmus MC
Rotterdam, 3000 CA, Netherlands
University Hospital
Barcelona, Spain
University Hospital
Madrid, 28046, Spain
Hospital de Condia(CHUS) RVA Ramon Baltar S/N
Santiago de Compostela, Spain
University Hospital Virgen del Rocio
Seville, 41013, Spain
Aberdeen Royal Infirmary
Aberdeen, United Kingdom
University Hospital
Cambridge, United Kingdom
Université Hospital
Cardiff, United Kingdom
Endocrinology and Metabolism Churchill Hospital
Oxford, United Kingdom
Related Publications (2)
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.
PMID: 34313752DERIVEDGiustina 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.
PMID: 31338660DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ipsen Medical Director
Ipsen
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 7, 2015
First Posted
September 3, 2015
Study Start
July 1, 2015
Primary Completion
September 3, 2018
Study Completion
September 3, 2018
Last Updated
November 1, 2018
Record last verified: 2018-10