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

Recruiting

• Conditions: Acromegaly

• Registration Number: NCT06597383
• Lead Sponsor: IRCCS San Raffaele

Brief 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.

Study Timeline

• Study Start: 2023-11-24
• Status Verified: 2024-09
• Study First Submitted: 2024-09-11
• Study First Submitted QC: 2024-09-11
• Last Update Submitted: 2024-09-11
• Study First Posted: 2024-09-19
• Last Update Posted: 2024-09-19
• Primary Completion: 2024-11
• Study Completion: 2024-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• 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
• Signature of the informed consent to the study

Exclusion Criteria

• age ≤18 years
• Pregnant and/or breastfeeding women
• Patients unable to understand and sign the Informed Consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluate the impact of TTS on disease control in acromegalic patients defined by IGF-1 levels <1.3xULN	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.

Trial Locations

Locations (1)

Andrea Giustina; 🇮🇹 Milan, Italy