AcromegalySAGITNCT02539927
Validation Study of the SAGIT® Instrument in Acromegaly
An observational study of Acromegaly, run by Ipsen at 33 sites in 10 countries.
Trial summary
Patients will be treated in accordance with the standard medical practice of the hospital where they have been recruited during their participation in this study. No additional assessments or tests will be required. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acromegaly
- How many people
- 227 participants
- Where
- 33 sitesin 10 countries
- Study dates
- Jul 2015to 3 Sep 2018
- 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: Patients suffering from Acromegaly in specialist care clinics and hospital clinics.
Who may be able to join
- Male or female aged 18 years-old or above at study inclusion
- Treatment-naïve and non treatment-naïve patients with a diagnosis of acromegaly
- Data required to complete the SAGIT® tool are available in the patient medical records and do not require additional assessments or tests
- Data required to complete the SAGIT® tool are recorded within the 3 months preceding the inclusion visit (6 months for MRI)
Who cannot join
- Acute uncontrolled disease requiring intensive care
Trial locations and contacts
33 sites in 10 countries.
33 sites in 10 countries
Italy5 sites
Ospedaliera Spedali Civili di Brescia
Montichiari, 25018
Azienda Ospedaliero Universitar a Fedderico II
Naples
Azienda Ospedaliera di Padova
Padova
Azienda Ospedaliero Universitaria Pisana-Endcrinologia 2
Pisa
Endocrinology, University Hospital, Policlinica Gemelu
Rome, 00168
United States4 sites
The Emory Pituitary Center
Atlanta, Georgia, 30322
Cleveland Clinic
Cleveland, Ohio, 44195
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Endocrinology and Metabolism
Pittsburgh, Pennsylvania, 15212
France4 sites
Hopital Neuro-Cardiologique
Bron, 69677
Hopital de Bicêtre
Le Kremlin-Bicêtre, 94275
CHU de Marseille - Hôpital de la Timone
Marseille, 13385
CHU Larrey
Toulouse, 31400
Spain4 sites
University Hospital
Barcelona
University Hospital
Madrid, 28046
Hospital de Condia(CHUS) RVA Ramon Baltar S/N
Santiago de Compostela
University Hospital Virgen del Rocio
Seville, 41013
United Kingdom4 sites
Aberdeen Royal Infirmary
Aberdeen
University Hospital
Cambridge
Université Hospital
Cardiff
Endocrinology and Metabolism Churchill Hospital
Oxford
Brazil3 sites
Federal University of Rio de Janeiro
Rio de Janeiro, 21941-913
University Hospital
São Paulo, 0503900
University Hospital
São Paulo
Germany3 sites
University Hospital
Essen, 45147
Endoc Zentrum Fûr Endokrine Tumoren
Hamburg, 20357
Private Clinique
Oldenburg, 26122
Netherlands3 sites
LUMC Leiden,
Leiden, 2333 2A
Radbound UMC
Nijmegen
Erasmus MC
Rotterdam, 3000 CA
Denmark2 sites
Department of Clinical Medicine - The Department of Endocrinology and Diabetes
Aarhus C, 8000
University Hospital, Dept of Endocrinology
Copenhagen, 2100
About this study
Official title: International Multicentre Validation Study of SAGIT® Instrument in Acromegaly
Patients will be treated in accordance with the standard medical practice of the hospital where they have been recruited during their participation in this study. No additional assessments or tests will be required.
SAGIT® is a new instrument developed by a group of acromegaly experts to help practicing endocrinologists to manage acromegalic patients and disease activity in their clinical practice and define acromegaly staging. It reports 5 elements: Signs and symptoms - S; Associated comorbidities - A; Growth hormone (GH) concentration - G; Insulin-like growth factor 1(IGF-1) concentration -I; Tumour size- T.
The instrument has been pre evaluated during a qualitative pilot study. The purpose of the validation study is to define and validate the scoring of the SAGIT® instrument.
- Conditions
- Acromegaly
- Medical subject headings
- Acromegaly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Controlled | Not described | |
| Not controlled | Not described | |
| Control status yet to be clarified | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Define and validate the scoring of the SAGIT® instrument
Evaluating the ability of the instrument to discriminate subgroups of subjects with acromegaly (controlled vs not controlled).
Measured: baseline
Secondary outcomes (3)
The ability of the SAGIT® instrument to predict the occurrence of significant clinical event(s) and/or treatment change(s) over time.
Significant clinical event is defined as death, stroke, onset of diabetes, onset of arthritis/onset of arthritis disability, myocardial infarction and/or diagnosis of other tumor; treatment change is defined as change in therapeutic doses, in therapeutic drug class, surgery or radiotherapy.
Measured: 2 years
Define SAGIT® characteristics for different groups
Controlled vs. non controlled. Treatment-naïve, patients vs. currently treated vs. previously treated patients
Measured: 2 years
The association between the SAGIT® tool and patients' quality of life measured using Acromegaly Quality of Life (AcroQoL) scores.
Acromegaly Quality of Life (AcroQoL) scores will be compared between patient groups defined according to SAGIT scoring algorithm (controlled vs. not controlled). This comparison will be performed using t-tests for each available visit of the prospective population.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2015 (estimated)
- Study startJul 2015
- Primary completion3 Sep 2018
- Study completion3 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Other
- Enrolment
- 227 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ipsen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ipsen Medical Director, Study director, Ipsen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02539927
- Sponsor's protocol ID
- 8-79-52030-295
- Acronym
- SAGIT
- Status last verified
- Oct 2018
- First submitted
- 7 Jul 2015
- Last updated
- 1 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Giustina A, Bronstein MD, Chanson P, Petersenn S, Casanueva FF, Sert C, Houchard A, Melmed S. International Multicenter Validation Study of the SAGIT(R) Instrument in Acromegaly. J Clin Endocrinol Metab. 2021 Nov 19;106(12):3555-3568. doi: 10.1210/clinem/dgab536.
PubMed 34313752Giustina A, Bronstein MD, Chanson P, Petersenn S, Casanueva FF, Sert C, Houchard A, Melmed S. Staging and managing patients with acromegaly in clinical practice: baseline data from the SAGIT(R) validation study. Pituitary. 2019 Oct;22(5):476-487. doi: 10.1007/s11102-019-00977-5.
PubMed 31338660
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- International Multicentre Validation Study of SAGIT® Instrument in Acromegaly
- ClinicalTrials.gov ID
- NCT02539927
- Acronym / sponsor ID
- SAGIT / 8-79-52030-295
- Conditions
- Acromegaly
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 227 participants (actual)
- Lead sponsor
- IpsenIndustry (pharma, biotech, devices)
- Study start
- Jul 2015 (actual)
- Primary completion
- 3 Sep 2018 (actual)
- Study completion
- 3 Sep 2018 (actual)
- First posted
- 3 Sep 2015 (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.
Patients will be treated in accordance with the standard medical practice of the hospital where they have been recruited during their participation in this study. No additional assessments or tests will be required.
SAGIT® is a new instrument developed by a group of acromegaly experts to help practicing endocrinologists to manage acromegalic patients and disease activity in their clinical practice and define acromegaly staging. It reports 5 elements: Signs and symptoms - S; Associated comorbidities - A; Growth hormone (GH) concentration - G; Insulin-like growth factor 1(IGF-1) concentration -I; Tumour size- T.
The instrument has been pre evaluated during a qualitative pilot study. The purpose of the validation study is to define and validate the scoring of the SAGIT® instrument.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Controlled | – | – |
| Not controlled | – | – |
| Control status yet to be clarified | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients suffering from Acromegaly in specialist care clinics and hospital clinics.
Key inclusion criteria (4 listed)
- Male or female aged 18 years-old or above at study inclusion
- Treatment-naïve and non treatment-naïve patients with a diagnosis of acromegaly
- Data required to complete the SAGIT® tool are available in the patient medical records and do not require additional assessments or tests
- Data required to complete the SAGIT® tool are recorded within the 3 months preceding the inclusion visit (6 months for MRI)
Key exclusion criteria (1 listed)
- Acute uncontrolled disease requiring intensive care
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Define and validate the scoring of the SAGIT® instrument
Time frame: baseline
Evaluating the ability of the instrument to discriminate subgroups of subjects with acromegaly (controlled vs not controlled).
3 secondary outcomes
The ability of the SAGIT® instrument to predict the occurrence of significant clinical event(s) and/or treatment change(s) over time.
Time frame: 2 years
Define SAGIT® characteristics for different groups
Time frame: 2 years
The association between the SAGIT® tool and patients' quality of life measured using Acromegaly Quality of Life (AcroQoL) scores.
Time frame: 2 years
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 1 Nov 2018.
- Derived from this study: PubMed 34313752Giustina A, Bronstein MD, Chanson P, Petersenn S, Casanueva FF, Sert C, Houchard A, Melmed S. International Multicenter Validation Study of the SAGIT(R) Instrument in Acromegaly. J Clin Endocrinol Metab. 2021 Nov 19;106(12):3555-3568. doi: 10.1210/clinem/dgab536.
- Derived from this study: PubMed 31338660Giustina A, Bronstein MD, Chanson P, Petersenn S, Casanueva FF, Sert C, Houchard A, Melmed S. Staging and managing patients with acromegaly in clinical practice: baseline data from the SAGIT(R) validation study. Pituitary. 2019 Oct;22(5):476-487. doi: 10.1007/s11102-019-00977-5.
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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 Medical Director study director
Ipsen
33 sites in 10 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 33 sites in 10 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 4 inclusion and 1 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 1 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in Italy, United States, France, Spain, United Kingdom and 5 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?
Define and validate the scoring of the SAGIT® instrument (time frame: baseline). 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 NCT02539927, which also lists 2 linked publications.
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 1 Nov 2018.