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NCT02231593 Clinical Trial

SAGIT for Classification of Patients With Acromegaly in Clinical Practice

Acromegaly Clinical Trial

— SAGIT Pilot  

Official title:
Pilot Testing of SAGIT in Patients With Acromegaly in Clinical Practice

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02231593
Other study ID # 8-79-52030-257
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 2013
Est. completion date May 2014

Study information
Verified date March 2020
Source Ipsen
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 71
Est. completion date May 2014
Est. primary completion date May 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• SAGIT
SAGIT is a Clinician-Reported Outcomes (ClinROs) tool

Locations
Country Name City State
Brazil Federal University of Minas Gerais Belo Horizonte
Brazil Private practice Curitiba
Brazil University of São Paulo Medical School São Paulo
Brazil Private practice Saúde
France CHU Bicetre Le Kremlin-Bicêtre
France Hôpital Huriez, CHRU DE Lille Lille
France CHU Rennes Hôpital sud Rennes
Germany Praxisgemeinschaft an der Kaisereiche, Wilhelm-Hauff-Straße 21 Berlin
Germany Universitätsklinikum Hamburg-Eppendorf Hamburg
Germany LMU München München
Italy Azienda Ospedaliera Spedali Civil di Brescia Brescia
Italy Montichiari Hospital Montichiari
Italy Azienda Ospedaliera Città della Salute e della Scienza Torino
Italy San Giovanni Battista Hospital Torino
Spain Hospital Universitario La Coruna La Coruna
Spain Universitary Hospital Virgen de la Vitoria Málaga
United Kingdom Aberdeen Royal Infirmary Aberdeen
United Kingdom Leeds General Infirmary Leeds
United Kingdom Derriford Hospital Plymouth
United States Cedars-Sinai Medical Center Los Angeles California
United States NW Pituitary Center and Neurological Surgery Portland Oregon

Sponsors (1)
Lead Sponsor Collaborator
Ipsen

Countries where clinical trial is conducted

United States,  Brazil,  France,  Germany,  Italy,  Spain,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of acromegaly patients classified using SAGIT 8 months
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Active, not recruiting NCT03252353 - Efficacy and Safety of Octreotide Capsules (MYCAPSSA) in Acromegaly Phase 3