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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Controlled | |||
| Not controlled | |||
| Control status yet to be clarified |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients suffering from Acromegaly in specialist care clinics and hospital clinics.
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| Name | Affiliation | Role |
|---|---|---|
| Ipsen Medical Director | Ipsen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | United States | ||
| The Emory Pituitary Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34313752 | Derived | 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. | |
| 31338660 | Derived | 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. |
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| 2 years |
| Define SAGIT® characteristics for different groups | Controlled vs. non controlled. Treatment-naïve, patients vs. currently treated vs. previously treated patients | 2 years |
| 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 |
| 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 | Padova | 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 |
| ID | Term |
|---|---|
| D000172 | Acromegaly |
| ID | Term |
|---|---|
| D001849 | Bone Diseases, Endocrine |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D006964 | Hyperpituitarism |
| D010900 | Pituitary Diseases |
| D007027 | Hypothalamic Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D004700 | Endocrine System Diseases |
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