The RApid Switch From 1st Generation Somatostatin Analogues to PaSireOtiDe In Acromegaly
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Acromegaly. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The RApid Switch From 1st Generation Somatostatin Analogues to PaSireOtiDe In Acromegaly ( RAPSODIA )
Overview
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.
Primary outcome measures
- Evaluate the impact of TTS on disease control in acromegalic patients defined by IGF-1 levels <1.3xULN [Time frame: 12 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
Italy · 1 center
- Andrea Giustina — Milan
Identifiers
NCT: NCT06597383 · RAPSODIA