Validation Study of the SAGIT® Instrument in Acromegaly

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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Key information

Conditions

Acromegaly Bone Diseases Bone Diseases, Endocrine Brain Diseases Central Nervous System Diseases Endocrine System Diseases Hyperpituitarism Hypothalamic Diseases Musculoskeletal Diseases Nervous System Diseases Pituitary Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Liège, Liège, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Time frame: 2 years

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.
Define SAGIT® characteristics for different groups

Time frame: 2 years

Controlled vs. non controlled. Treatment-naïve, patients vs. currently treated vs. previously treated patients
The association between the SAGIT® tool and patients' quality of life measured using Acromegaly Quality of Life (AcroQoL) scores.

Time frame: 2 years

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.

Sponsors and collaborators

Lead sponsor

Ipsen

Industry

Registry information

Official study title

International Multicentre Validation Study of SAGIT® Instrument in Acromegaly

Acronym: SAGIT

Important dates

Study start: 2015
Primary completion: 2018
Study completion: 2018
First posted: Sep 3, 2015
Registry last updated: Nov 1, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed