Validation Study of the SAGIT® Instrument in Acromegaly
| Status: | Completed |
|---|---|
| Conditions: | Skin Cancer, Endocrine |
| Therapuetic Areas: | Endocrinology, Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 11/3/2018 |
| Start Date: | July 2015 |
| End Date: | September 3, 2018 |
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.
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.
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
We found this trial at
5
sites
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Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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