Acromegaly
Conditions
Keywords
somatostatin analogues, pasireotide, pegvisomant
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.
Interventions
None listed
Sponsors
University of Turin, Italy
University of Padova
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IRCCS San Raffaele
Study design
Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Italy
Contacts
Primary ContactLuigi Di Filippo, medical doctor
Backup ContactGabriela Felipe, clinical research nurse
Outcome results
None listed