SAGIT VALIDATION STUDY
Research type
Research Study
Full title
INTERNATIONAL MULTICENTRE VALIDATION STUDY OF SAGIT TOOL IN ACROMEGALY
IRAS ID
174231
Contact name
Szilvia Fabian
Contact email
Sponsor organisation
Ipsen Group
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
This international study is taking place in 10 countries, in approximately 35 centres over a 3 year period. It is a non-interventional study (i.e. no medical procedures will take place as part of this study) looking at data collected prospectively (in the future) and retrospectively (in the past) for patients suffering from acromegaly (a disorder of the endocrine system caused by excessive growth hormone[GH] and insulin-like growth factor-1 [IGF-1] which is a growth factor). The data will be used to validate SAGIT – a new tool developed by a group of acromegaly experts to help practicing consultants who specialise in looking at the endocrine system (endocrinologists) to manage patients suffering with acromegaly and their disease activity in clinical practice and to define how to grade acromegaly (staging). Acromegaly is a chronic (long-lasting) endocrine disorder caused by excessive GH and IGF-1 production that is caused predominantly by a non-cancerous tumour (benign adenoma) of the pituitary gland which is a gland which controls many bodily functions.\nThe purpose of this study is to validate and define the scoring of a new document called SAGIT tool. This tool was developed by acromegaly experts to help doctors describe acromegaly patients and disease activity in their clinical practice and define acromegaly staging. It reports 5 elements: Signs and symptoms - S; Associated comorbidities (additional diseases) - A; Growth hormone (GH) concentration level - G; Insulin growth factor 1(IGF-1) -I; Tumour - T. The content and usefulness of the SAGIT tool have been confirmed in a qualitative pre-testing study involving 30 acromegaly patients conducted with a targeted endocrinologist population. To date, no structured tool is available as a reference in clinical practice to define patients with acromegaly before and during treatment. Providing practicing endocrinologists with a tool to aid classification of patients with acromegaly will be useful. This would help standardize the evaluation and categorization of patients with acromegaly across countries, thus allowing their comparison, and it would help practicing endocrinologists make decisions about treatment and optimize the management of patients.\n\n\n
REC name
North of Scotland Research Ethics Committee 2
REC reference
15/NS/0023
Date of REC Opinion
25 May 2015
REC opinion
Further Information Favourable Opinion