Predictive Value of 3 Months Results on 12 Months Tumor Shrinkage After First-Line Octreotide-LAR Therapy in Patients With Acromegaly
From Jan 1st 1995 to December 31st 2006, all files of patients with newly diagnosed active
acromegaly out of the 297 patients coming to our Department for acromegaly who received
first-line treatment with LAR will be considered for this study.
As our routine procedure, all patients signed an informed consent to approve diagnostic
testing, treatment decision, methods for follow-up and data treatment for scientific
purposes. This study has been conducted in accordance with the Helsinki II Declaration on
human experimentation. This study takes advantage from data collected in a large,
prospective study to investigate the effect of first-line surgery or medical therapy (with
somatostatin analogues and/or dopamine/agonists) on GH, IGF-I, tumor mass, cardiovascular
risk markers, cardiomyopathy, hypertension, metabolic profile and prostate diseases in all
the patients coming for a diagnosis of acromegaly in our Department and approved by our
Ethical Committee the 14/10/97 (no.60/97).
Observational
Observational Model: Cohort, Time Perspective: Retrospective
GH and IGF-I age-normalized levels, percent GH and IGF-I suppression and percent tumor shrinkage after 3 months
12 months
No
Annamaria Colao, MD
Principal Investigator
University Federico II of Naples
Italy: National Institute of Health
NeuroendoUnit-8
NCT00616408
January 1997
December 2007
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