SAGIT for Classification of Patients With Acromegaly in Clinical Practice (SAGIT Pilot)

Ipsen

Status: Completed

Conditions: Acromegaly

Treatments: Other: SAGIT

Study type: Observational

Funder types: Industry

Identifiers

NCT02231593

8-79-52030-257

Details and patient eligibility

About

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.

Enrollment: 71 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

71 participants in 1 patient group

Acromegalic patients

Treatment:

Other: SAGIT