Clincosm LogoSign in Get a demo

SAGIT Pilot: SAGIT for Classification of Patients With Acromegaly in Clinical Practice

Sponsor
Ipsen (Industry)
Overall Status
Completed
CT.gov ID
NCT02231593
Collaborator
(none)
71
Enrollment
21
Locations
14.9
Duration (Months)
3.4
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: SAGIT

Study Design

Study Type:
Observational
Actual Enrollment :
71 participants
Observational Model:
Cohort
Time Perspective:
Cross-Sectional
Official Title:
Pilot Testing of SAGIT in Patients With Acromegaly in Clinical Practice
Study Start Date :
Feb 1, 2013
Actual Primary Completion Date :
May 1, 2014
Actual Study Completion Date :
May 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Acromegalic patients

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

Outcome Measures

Primary Outcome Measures

  1. Number of acromegaly patients classified using SAGIT [8 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Cedars-Sinai Medical Center Los Angeles California United States 90048
2 NW Pituitary Center and Neurological Surgery Portland Oregon United States 97239
3 Federal University of Minas Gerais Belo Horizonte Brazil 31270-901
4 Private practice Curitiba Brazil 80210070
5 Private practice Saúde Brazil 04143020
6 University of São Paulo Medical School São Paulo Brazil 01246903
7 CHU Bicetre Le Kremlin-Bicêtre France 94275
8 Hôpital Huriez, CHRU DE Lille Lille France 59000
9 CHU Rennes Hôpital sud Rennes France
10 Praxisgemeinschaft an der Kaisereiche, Wilhelm-Hauff-Straße 21 Berlin Germany 12159
11 Universitätsklinikum Hamburg-Eppendorf Hamburg Germany 20246
12 LMU München München Germany 80336
13 Azienda Ospedaliera Spedali Civil di Brescia Brescia Italy 25128
14 Montichiari Hospital Montichiari Italy 25018
15 Azienda Ospedaliera Città della Salute e della Scienza Torino Italy 10126
16 San Giovanni Battista Hospital Torino Italy 10126
17 Hospital Universitario La Coruna La Coruna Spain 15002
18 Universitary Hospital Virgen de la Vitoria Málaga Spain 29010
19 Aberdeen Royal Infirmary Aberdeen United Kingdom AB25 2ZN
20 Leeds General Infirmary Leeds United Kingdom LS1 3EX
21 Derriford Hospital Plymouth United Kingdom PL6 8DH

Sponsors and Collaborators

  • Ipsen

Investigators

  • Study Director: Ipsen Study Director, Ipsen

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ipsen
ClinicalTrials.gov Identifier:
NCT02231593
Other Study ID Numbers:
  • 8-79-52030-257
First Posted:
Sep 4, 2014
Last Update Posted:
Mar 31, 2020
Last Verified:
Mar 1, 2020
Additional relevant MeSH terms:
Acromegaly

Study Results

No Results Posted as of Mar 31, 2020