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| Name | Class |
|---|---|
| University of Turin, Italy | OTHER |
| University of Padova | OTHER |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS | OTHER |
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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.
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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with acromegaly treated with second-line medical therapy.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Luigi Di Filippo, medical doctor | Contact | +39 0226435062 | difilippo.luigi@hsr.it | |
| Gabriela Felipe, clinical research nurse | Contact | +39 0226435062 | felipe.gabriela@hsr.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Andrea Giustina | Recruiting | Milan | 20132 | Italy |
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| ID | Term |
|---|---|
| D000172 | Acromegaly |
| ID | Term |
|---|---|
| D001849 | Bone Diseases, Endocrine |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D006964 | Hyperpituitarism |
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| D010900 |
| Pituitary Diseases |
| D007027 | Hypothalamic Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D004700 | Endocrine System Diseases |