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NCT Number: NCT06597383

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Andrea Giustina

Milan, 20132, Italy

Location status: Recruiting

Location contact

Gabriela Felipe, nurse

CONTACT

[email protected]

0226435062

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Gabriela Felipe, clinical research nurse

CONTACT

[email protected]

+39 0226435062

Luigi Di Filippo, medical doctor

CONTACT

[email protected]

+39 0226435062

Sponsors and collaborators

Lead sponsor

IRCCS San Raffaele

Other

Collaborators

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

Registry information

Official study title

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

Acronym: RAPSODIA

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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