SAGIT for Classification of Patients With Acromegaly in Clinical Practice

Ipsen71 enrolled

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Acromegaly

Interventions

SAGITOTHER

SAGIT is a Clinician-Reported Outcomes (ClinROs) tool

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (21)

Cedars-Sinai Medical Center

Los Angeles, California, United States

NW Pituitary Center and Neurological Surgery

Portland, Oregon, United States

Outcomes

Primary Outcomes

Number of acromegaly patients classified using SAGIT

Time frame: 8 months

Data from ClinicalTrials.gov

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