International Multicentre Validation Study of SAGIT® Instrument in Acromegaly
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Ipsen
- Enrollment
- 227
- Locations
- 28
- Primary Endpoint
- Define and validate the scoring of the SAGIT® instrument
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Other
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Define and validate the scoring of the SAGIT® instrument
Time Frame: baseline
Evaluating the ability of the instrument to discriminate subgroups of subjects with acromegaly (controlled vs not controlled).
Secondary Outcomes
- 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)