AcromegalySAGIT PilotNCT02231593
SAGIT for Classification of Patients With Acromegaly in Clinical Practice
An observational study of Acromegaly, run by Ipsen at 21 sites in 7 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acromegaly
- What is being tested?
- SAGIT
- How many people
- 71 participants
- Where
- 21 sitesin 7 countries
- Study dates
- Feb 2013to May 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Acromegaly patients registered with endocrinologists (hospital-based or outpatient clinics)
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
21 sites in 7 countries.
21 sites in 7 countries
Brazil4 sites
Federal University of Minas Gerais
Belo Horizonte, 31270-901
Private practice
Curitiba, 80210070
University of São Paulo Medical School
São Paulo, 01246903
Private practice
Saúde, 04143020
Italy4 sites
Azienda Ospedaliera Spedali Civil di Brescia
Brescia, 25128
Montichiari Hospital
Montichiari, 25018
Azienda Ospedaliera Città della Salute e della Scienza
Torino, 10126
San Giovanni Battista Hospital
Torino, 10126
France3 sites
CHU Bicetre
Le Kremlin-Bicêtre, 94275
Hôpital Huriez, CHRU DE Lille
Lille, 59000
CHU Rennes Hôpital sud
Rennes
Germany3 sites
Praxisgemeinschaft an der Kaisereiche, Wilhelm-Hauff-Straße 21
Berlin, 12159
Universitätsklinikum Hamburg-Eppendorf
Hamburg, 20246
LMU München
München, 80336
United Kingdom3 sites
Aberdeen Royal Infirmary
Aberdeen, AB25 2ZN
Leeds General Infirmary
Leeds, LS1 3EX
Derriford Hospital
Plymouth, PL6 8DH
United States2 sites
Cedars-Sinai Medical Center
Los Angeles, California, 90048
NW Pituitary Center and Neurological Surgery
Portland, Oregon, 97239
Spain2 sites
Hospital Universitario La Coruna
A Coruña, 15002
Universitary Hospital Virgen de la Vitoria
Málaga, 29010
About this study
Official title: 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.
- Conditions
- Acromegaly
- Being tested
- SAGIT
- Medical subject headings
- Acromegaly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAGITOther
SAGIT is a Clinician-Reported Outcomes (ClinROs) tool
| Study group | Role | What they receive |
|---|---|---|
| Acromegalic patients | Not described Receives: Other: SAGIT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of acromegaly patients classified using SAGIT
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2014 (estimated)
- Study startFeb 2013
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AcromegalyStudies of the same condition, open and under way.
- More trials run by IpsenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ipsen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ipsen Study Director, Study director, Ipsen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02231593
- Sponsor's protocol ID
- 8-79-52030-257
- Acronym
- SAGIT Pilot
- Status last verified
- Mar 2020
- First submitted
- 2 Sep 2014
- Last updated
- 31 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26377024
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Testing of SAGIT in Patients With Acromegaly in Clinical Practice
- ClinicalTrials.gov ID
- NCT02231593
- Acronym / sponsor ID
- SAGIT Pilot / 8-79-52030-257
- Conditions
- Acromegaly
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- IpsenIndustry (pharma, biotech, devices)
- Study start
- Feb 2013
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 4 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acromegalic patients | – | Other: SAGIT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Acromegaly patients registered with endocrinologists (hospital-based or outpatient clinics)
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SAGITSAGIT is a Clinician-Reported Outcomes (ClinROs) tool | Other | Acromegalic patients |
Primary outcome
Number of acromegaly patients classified using SAGIT
Time frame: 8 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2020.
- Derived from this study: PubMed 26377024Giustina 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ipsen Study Director study director
Ipsen
21 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acromegaly, run by Ipsen at 21 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in Brazil, Italy, France, Germany, United Kingdom and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of acromegaly patients classified using SAGIT (time frame: 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02231593, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2020.