Somatuline Predictive Factors in Acromegaly and NET

Overview

The aim of the study is to identify predictive factors for the response to Lanreotide treatment in Acromegaly as well as in Neuroendocrine Tumours.

Full Title of Study: “Non-interventional, Observational Study to Evaluate Common Therapeutic Algorithms and Possible Predictive Parameters for Somatuline Autogel® (ATG) Treatment in Subjects With Either Acromegaly or Neuroendocrine Tumours (NET)”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: July 2016

Interventions

  • Drug: Somatuline Autogel® 60, 90 or 120 mg

Arms, Groups and Cohorts

  • Neuroendocrine Tumours
    • The subject will receive treatment as prescribed by the investigator and in accordance with the current recommendations, routine practice and local regulations.
  • Acromegaly
    • The subject will receive treatment as prescribed by the investigator and in accordance with the current recommendations, routine practice and local regulations.

Clinical Trial Outcome Measures

Primary Measures

  • Change in biochemical markers (Growth Hormone [GH] & Insulin-like Growth Factor 1 [IGF-1] in acromegaly subjects and Chromogranin A [CgA] in NET subjects)
    • Time Frame: Baseline and 1 year

Secondary Measures

  • Change in biochemical markers (Growth Hormone [GH] & Insulin-like Growth Factor 1 [IGF-1] in acromegaly subjects and Chromogranin A [CgA] in NET subjects)
    • Time Frame: Baseline and 2 years

Participating in This Clinical Trial

Inclusion Criteria

  • Written informed consent (also mandatory in case of retrospective documentation of subject data) – Diagnosis of acromegaly or NET with the intention to be treated with ATG or already on treatment with ATG Exclusion Criteria:

  • The subject has already been included in this study – Participation in an interventional trial

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Ipsen
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Ipsen Medical Director, Study Director, Ipsen

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