Andrea Giustina
Milan, 20132, Italy
Location status: Recruiting
NCT Number: NCT06597383
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Milan, 20132, Italy
Location status: Recruiting
The study will retrospectively collect clinical, laboratory and anamnestic data of approximately 100 patients evaluated at the UOs involved in the study in last 5 years and 6 months.
Acromegalic patients which neurosurgical intervention was not completely effective or contraindicated or rejected by the patient and for which first-line medical therapy with first-generation somatostatin analogues (octreotide LAR or lanreotide) did not result in disease control and switched to second-line medical therapy will be enrolled. The TTS is the time defined in days and months from the observation that disease is no longer biochemically controlled, defined by the presence of GH levels ≥1 μg/L and IGF-1>1.3×ULN (upper limit of normal), during 1st line therapy, and the start of 2nd line therapy line.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 12 months
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.
Contact information is provided by the study sponsor or research team.
Gabriela Felipe, clinical research nurse
CONTACT
Luigi Di Filippo, medical doctor
CONTACT
IRCCS San Raffaele
Other
The RApid Switch From 1st Generation Somatostatin Analogues to PaSireOtiDe In Acromegaly ( RAPSODIA )
Acronym: RAPSODIA
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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