SAGIT for Classification of Patients With Acromegaly in Clinical Practice (SAGIT Pilot)
March 30, 2020 updated by: Ipsen
Pilot Testing of SAGIT in Patients With Acromegaly in Clinical Practice
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 Overview
Study Type
Observational
Enrollment (Actual)
71
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Belo Horizonte, Brazil, 31270-901
- Federal University of Minas Gerais
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Curitiba, Brazil, 80210070
- Private practice
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Saúde, Brazil, 04143020
- Private practice
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São Paulo, Brazil, 01246903
- University of Sao Paulo Medical School
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Le Kremlin-Bicêtre, France, 94275
- CHU Bicetre
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Lille, France, 59000
- Hopital Huriez, CHRU de Lille
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Rennes, France
- CHU Rennes Hôpital Sud
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Berlin, Germany, 12159
- Praxisgemeinschaft an der Kaisereiche, Wilhelm-Hauff-Straße 21
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Hamburg, Germany, 20246
- Universitätsklinikum Hamburg-Eppendorf
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München, Germany, 80336
- LMU München
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Brescia, Italy, 25128
- Azienda Ospedaliera Spedali Civil di Brescia
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Montichiari, Italy, 25018
- Montichiari Hospital
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Torino, Italy, 10126
- Azienda Ospedaliera Citta della Salute e della Scienza
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Torino, Italy, 10126
- San Giovanni Battista Hospital
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La Coruna, Spain, 15002
- Hospital Universitario La Coruna
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Málaga, Spain, 29010
- Universitary Hospital Virgen de la Vitoria
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Aberdeen, United Kingdom, AB25 2ZN
- Aberdeen Royal Infirmary
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Leeds, United Kingdom, LS1 3EX
- Leeds General Infirmary
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Plymouth, United Kingdom, PL6 8DH
- Derriford Hospital
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California
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Los Angeles, California, United States, 90048
- Cedars-Sinai Medical Center
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Oregon
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Portland, Oregon, United States, 97239
- NW Pituitary Center and Neurological Surgery
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Acromegaly patients registered with endocrinologists (hospital-based or outpatient clinics)
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Acromegalic patients
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SAGIT is a Clinician-Reported Outcomes (ClinROs) tool
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Number of acromegaly patients classified using SAGIT
Time Frame: 8 months
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8 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2013
Primary Completion (Actual)
May 1, 2014
Study Completion (Actual)
May 1, 2014
Study Registration Dates
First Submitted
September 2, 2014
First Submitted That Met QC Criteria
September 2, 2014
First Posted (Estimate)
September 4, 2014
Study Record Updates
Last Update Posted (Actual)
March 31, 2020
Last Update Submitted That Met QC Criteria
March 30, 2020
Last Verified
March 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 8-79-52030-257
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.