NCT02231593

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
71

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2013

Geographic Reach
7 countries

21 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 2, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 4, 2014

Completed
Last Updated

March 31, 2020

Status Verified

March 1, 2020

Enrollment Period

1.2 years

First QC Date

September 2, 2014

Last Update Submit

March 30, 2020

Conditions

Acromegaly

Outcome Measures

Primary Outcomes (1)

  • Number of acromegaly patients classified using SAGIT

    8 months

Study Arms (1)

Acromegalic patients

Other: SAGIT

Interventions

SAGITOTHER

SAGIT is a Clinician-Reported Outcomes (ClinROs) tool

Acromegalic patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Acromegaly patients registered with endocrinologists (hospital-based or outpatient clinics)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (21)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

NW Pituitary Center and Neurological Surgery

Portland, Oregon, 97239, United States

Location

Federal University of Minas Gerais

Belo Horizonte, 31270-901, Brazil

Location

Private practice

Curitiba, 80210070, Brazil

Location

Private practice

Saúde, 04143020, Brazil

Location

University of São Paulo Medical School

São Paulo, 01246903, Brazil

Location

CHU Bicetre

Le Kremlin-Bicêtre, 94275, France

Location

Hôpital Huriez, CHRU DE Lille

Lille, 59000, France

Location

CHU Rennes Hôpital sud

Rennes, France

Location

Praxisgemeinschaft an der Kaisereiche, Wilhelm-Hauff-Straße 21

Berlin, 12159, Germany

Location

Universitätsklinikum Hamburg-Eppendorf

Hamburg, 20246, Germany

Location

LMU München

München, 80336, Germany

Location

Azienda Ospedaliera Spedali Civil di Brescia

Brescia, 25128, Italy

Location

Montichiari Hospital

Montichiari, 25018, Italy

Location

Azienda Ospedaliera Città della Salute e della Scienza

Torino, 10126, Italy

Location

San Giovanni Battista Hospital

Torino, 10126, Italy

Location

Hospital Universitario La Coruna

A Coruña, 15002, Spain

Location

Universitary Hospital Virgen de la Vitoria

Málaga, 29010, Spain

Location

Aberdeen Royal Infirmary

Aberdeen, AB25 2ZN, United Kingdom

Location

Leeds General Infirmary

Leeds, LS1 3EX, United Kingdom

Location

Derriford Hospital

Plymouth, PL6 8DH, United Kingdom

Location

Related Publications (1)

  • Giustina A, Bevan JS, Bronstein MD, Casanueva FF, Chanson P, Petersenn S, Thanh XM, Sert C, Houchard A, Guillemin I, Melmed S; SAGIT Investigator Group. SAGIT(R): clinician-reported outcome instrument for managing acromegaly in clinical practice--development and results from a pilot study. Pituitary. 2016 Feb;19(1):39-49. doi: 10.1007/s11102-015-0681-2.

    PMID: 26377024DERIVED

MeSH Terms

Conditions

Acromegaly

Condition Hierarchy (Ancestors)

Bone Diseases, EndocrineBone DiseasesMusculoskeletal DiseasesHyperpituitarismPituitary DiseasesHypothalamic DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesEndocrine System Diseases

Study Officials

  • Ipsen Study Director

    Ipsen

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 2, 2014

First Posted

September 4, 2014

Study Start

February 1, 2013

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

March 31, 2020

Record last verified: 2020-03

Locations

BR(4)FR(3)DE(3)US(2)IT(4)ES(2)GB(3)