Validation Study of the SAGIT® Instrument in Acromegaly

NCT02539927 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 227

Last updated 2018-11-01

No results posted yet for this study

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.

Conditions

Sponsors & Collaborators

Principal Investigators

  • Ipsen Medical Director · Ipsen

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-31
Primary Completion
2018-09-03
Completion
2018-09-03

Countries

  • United States
  • Belgium
  • Brazil
  • Denmark
  • France
  • Germany
  • Italy
  • Netherlands
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02539927 on ClinicalTrials.gov