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

September 11, 2024 updated by: Andrea Giustina, IRCCS San Raffaele

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

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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
      • Milan, Italy, 20132
        • Recruiting
        • Andrea Giustina
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with acromegaly treated with second-line medical therapy.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the impact of TTS on disease control in acromegalic patients defined by IGF-1 levels <1.3xULN
Time Frame: 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.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS San Raffaele

Collaborators

Fondazione Policlinico Universitario Agostino Gemelli IRCCS
University of Padova
University of Turin, Italy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 24, 2023

Primary Completion (Estimated)

November 1, 2024

Study Completion (Estimated)

November 1, 2024

Study Registration Dates

First Submitted

September 11, 2024

First Submitted That Met QC Criteria

September 11, 2024

First Posted (Estimated)

September 19, 2024

Study Record Updates

Last Update Posted (Estimated)

September 19, 2024

Last Update Submitted That Met QC Criteria

September 11, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RAPSODIA

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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