The RApid Switch From 1st Generation Somatostatin Analogues to PaSireOtiDe In Acromegaly
ConditionAcromegaly
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorIRCCS San Raffaele
About this trial
This is an observational, retrospective, national multicenter study aimed to evaluate the impact and efficacy of Time To Switch (TTS) from first-line to second-line medical therapy in Acromegaly.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult men and women (age ≥ 18 years) affected by acromegaly, including those of childbearing age
Patients inadequately controlled with first generation somatostatin analogues (GH ≥1 μg/L and IGF-1 >1.3×ULN)
Second line medical treatment (Pasireotide; Pegvisomant only; combination Pegvisomant + 1st generation SSA) after use of first-line medical treatment
At least 12 months of follow up during 2nd line therapy
Disqualifiers
age ≤18 years
Pregnant and/or breastfeeding women
Patients unable to understand and sign the Informed Consent
Trial population
Patients with acromegaly treated with second-line medical therapy.
Trial design
Design model
Case-control
Time perspective
Retrospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Evaluate the impact of TTS on disease control in acromegalic patients defined by IGF-1 levels <1.3xULN
Retrospective data on biochemical and clinical outcomes of patients affected by acromegaly treated with second-line medical therapy will be collected and analyzed. The patients will be stratified based on the therapeutic switch time (Time To Switch, TTS) \< 6 months, between 6 and 12 months and \> 12 months, from 1st generation SSA to the different second-line medical approaches (Pasireotide; Pegvisomant alone; Pegvisomant + first generation SSA combination). The impact of TTS on the biochemical and clinical control of illness will be analyzed.
Time frame
12 monthsSponsors and contacts
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IRCCS San Raffaele
Lead sponsor
University of Turin, Italy
Collaborator
University of Padova
Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Collaborator
Source ClinicalTrials.gov