Validation Study of the SAGIT® Instrument in Acromegaly

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Acromegaly
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Novartis Pharmaceuticals – Acromegaly
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Brief Title

Validation Study of the SAGIT® Instrument in Acromegaly

Official Title

International Multicentre Validation Study of SAGIT® Instrument in Acromegaly

Brief 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.

      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 Type

Observational

Primary Outcome

Define and validate the scoring of the SAGIT® instrument

Secondary Outcome

 The ability of the SAGIT® instrument to predict the occurrence of significant clinical event(s) and/or treatment change(s) over time.

Condition

Acromegaly

Study Arms / Comparison Groups

 Controlled
Description:

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Estimated Enrollment

227

Start Date

July 2015

Completion Date

September 3, 2018

Primary Completion Date

September 3, 2018

Eligibility Criteria

        Inclusion Criteria:

          -  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)

        Exclusion Criteria:

          -  Acute uncontrolled disease requiring intensive care

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Ipsen Medical Director, ,

Location Countries

Belgium

Location Countries

Belgium

Administrative Informations

NCT ID

NCT02539927

Organization ID

8-79-52030-295

Responsible Party

Sponsor

Study Sponsor

Ipsen

Study Sponsor

Ipsen Medical Director, Study Director, Ipsen

Verification Date

October 2018