SAGIT for Classification of Patients With Acromegaly in Clinical Practice
| Status: | Completed |
|---|---|
| Conditions: | Skin Cancer, Endocrine |
| Therapuetic Areas: | Endocrinology, Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/16/2019 |
| Start Date: | February 2013 |
| End Date: | May 2014 |
Testing the Use of SAGIT for Classification of Patients With Acromegaly in Clinical Practice
The purpose of this pilot study is to test SAGIT (Signs and symptoms - Associated
comorbidities - GH concentration level - IGF-1 - Tumour). SAGIT is a Clinician-Reported
Outcomes (ClinROs) tool developed to describe patients with acromegaly. This study will
determine the potential use of a finalised operational version for patient classification in
clinical practice and studies.
In addition, this study intends to carry out a qualitative evaluation of the acceptability of
SAGIT by the practicing endocrinologist in terms of relevance, ease of use, applicability and
usefulness of the tool in practice.
comorbidities - GH concentration level - IGF-1 - Tumour). SAGIT is a Clinician-Reported
Outcomes (ClinROs) tool developed to describe patients with acromegaly. This study will
determine the potential use of a finalised operational version for patient classification in
clinical practice and studies.
In addition, this study intends to carry out a qualitative evaluation of the acceptability of
SAGIT by the practicing endocrinologist in terms of relevance, ease of use, applicability and
usefulness of the tool in practice.
Inclusion Criteria:
- Male or female aged 18 years-old or above
- Patient with diagnosis of acromegaly with the presence of pituitary adenoma, elevated
IGF-1 and lack of serum GH suppression after oral glucose tolerance test (OGTT)
- Controlled/stable, active and treatment naïve patients.
- Patient with the cognitive and linguistic capacities to understand the information
letter of the study
- Patient who signed informed consent
Exclusion Criteria:
- History of non-compliance or inability to reliably receive treatment in the
foreseeable future
- Gaps in treatment of greater than 1 month within the 12 months prior to study entry
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3
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