NCT06597383

The RApid Switch From 1st Generation Somatostatin Analogues to PaSireOtiDe In Acromegaly

The RApid Switch From 1st Generation Somatostatin Analogues to PaSireOtiDe In Acromegaly ( RAPSODIA )

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: IRCCS San Raffaele · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Acromegaly

Timeline

• Start date: 2023-11-24
• Primary completion: 2024-11-01
• Completion: 2024-11-01
• First posted: 2024-09-19
• Last updated: 2024-09-19

Locations

1 site across 1 country: Italy