Validation Study of the SAGIT® Instrument in Acromegaly

Ipsen227 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

227

Conditions

Acromegaly

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (33)

Cedars-Sinai Medical Center

Los Angeles, California, United States

The Emory Pituitary Center

Atlanta, Georgia, United States

Cleveland Clinic

Cleveland, Ohio, United States

Endocrinology and Metabolism

Pittsburgh, Pennsylvania, United States

CHU de Liège

Liège, Belgium

Federal University of Rio de Janeiro

Rio de Janeiro, Brazil

University Hospital

São Paulo, Brazil

University Hospital

São Paulo, Brazil

Department of Clinical Medicine - The Department of Endocrinology and Diabetes

Aarhus C, Denmark

University Hospital, Dept of Endocrinology

Copenhagen, Denmark

...and 23 more locations

Outcomes

Primary Outcomes

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).

Time frame: baseline

Secondary Outcomes

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.

Time frame: 2 years

Define SAGIT® characteristics for different groups

Controlled vs. non controlled. Treatment-naïve, patients vs. currently treated vs. previously treated patients

Time frame: 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.

Time frame: 2 years