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

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.