Validation Study of the SAGIT® Instrument in Acromegaly

Study Overview
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Brief Summary
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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.

Official Title
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International Multicentre Validation Study of SAGIT® Instrument in Acromegaly

Conditions
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Acromegaly

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Controlled<br> | |
| Not controlled<br> | |
| Control status yet to be clarified<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 |