SAGIT for Classification of Patients With Acromegaly in Clinical Practice
Overview
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.
Full Title of Study: “Pilot Testing of SAGIT in Patients With Acromegaly in Clinical Practice”
Study Type
- Study Type: Observational
- Study Design
- Time Perspective: Cross-Sectional
- Study Primary Completion Date: May 2014
Interventions
- Other: SAGIT
- SAGIT is a Clinician-Reported Outcomes (ClinROs) tool
Arms, Groups and Cohorts
- Acromegalic patients
Clinical Trial Outcome Measures
Primary Measures
- Number of acromegaly patients classified using SAGIT
- Time Frame: 8 months
Participating in This Clinical Trial
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
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Ipsen
- Provider of Information About this Clinical Study
- Sponsor
- Overall Official(s)
- Ipsen Study Director, Study Director, Ipsen
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