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Completed

NCT Number: NCT02231593

SAGIT for Classification of 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.

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Key information

Conditions

Acromegaly Bone Diseases Bone Diseases, Endocrine Brain Diseases Central Nervous System Diseases Endocrine System Diseases Hyperpituitarism Hypothalamic Diseases Musculoskeletal Diseases Nervous System Diseases Pituitary Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Federal University of Minas Gerais, Belo Horizonte, Brazil

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SAGIT

Other

SAGIT is a Clinician-Reported Outcomes (ClinROs) tool

Primary outcomes

  1. Number of acromegaly patients classified using SAGIT

    Time frame: 8 months

Sponsors and collaborators

Lead sponsor

Ipsen

Industry

Registry information

Official study title

Pilot Testing of SAGIT in Patients With Acromegaly in Clinical Practice

Acronym: SAGIT Pilot

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Sep 4, 2014
Registry last updated
Mar 31, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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