Actively Recruiting
Study of Rapid Switch from First-Generation Somatostatin Analogues to Pasireotide in Adults with Acromegaly
Led by IRCCS San Raffaele · Updated on 2024-09-19
100
Participants Needed
1
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are conducting an observational, retrospective, national multicenter study to evaluate the impact and effectiveness of the timing for switching from first-line to second-line medical therapy in patients with Acromegaly. The study focuses on patients whose disease was not controlled by initial treatment with first-generation somatostatin analogues octreotide LAR or lanreotide, either because surgery was ineffective, contraindicated, or rejected. The main goal is to understand how the time to switch TTS affects disease control. The study will collect clinical, laboratory, and historical data from about 100 patients treated over the past five and a half years. Eligible patients are those who switched from first-line therapy to second-line medications such as Pasireotide, Pegvisomant, or a combination of Pegvisomant with first-generation somatostatin analogues. Participants must have been followed for at least 12 months during their second-line treatment. Participants data will be reviewed to assess disease control, defined by specific hormone levels IGF-1 less than 1.3 times the upper limit of normal after 12 months of second-line therapy. The study involves gathering medical records and laboratory results without active intervention. Safety monitoring is not a primary focus since this is a retrospective study. The research aims to provide insights into the best timing for treatment changes in managing Acromegaly.
CONDITIONS
Brief Title
The RApid Switch From 1st Generation Somatostatin Analogues to PaSireOtiDe In Acromegaly
Research Team
L
Luigi Di Filippo, medical doctor
G
Gabriela Felipe, clinical research nurse
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