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Somatuline Predictive Factors in Acromegaly and NET (SOPRANo)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01840449
First Posted: April 25, 2013
Last Update Posted: July 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Ipsen
  Purpose
The aim of the study is to identify predictive factors for the response to Lanreotide treatment in Acromegaly as well as in Neuroendocrine Tumours.

Condition Intervention
Acromegaly Neuroendocrine Tumours Drug: Somatuline Autogel® 60, 90 or 120 mg

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by Ipsen:

Primary Outcome 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 Outcome 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 ]

Enrollment: 156
Study Start Date: June 2012
Study Completion Date: May 2017
Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Neuroendocrine Tumours
The subject will receive treatment as prescribed by the investigator and in accordance with the current recommendations, routine practice and local regulations.
Drug: Somatuline Autogel® 60, 90 or 120 mg
Acromegaly
The subject will receive treatment as prescribed by the investigator and in accordance with the current recommendations, routine practice and local regulations.
Drug: Somatuline Autogel® 60, 90 or 120 mg

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Clinics and private practitioners who treat acromegaly and/or NET subjects with Somatuline Autogel® 60, 90 or 120 mg.
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01840449


Locations
Austria
University Hospital of Vienna
Vienna, Austria
Germany
ENDOC
Hamburg, Germany
Switzerland
University Hospital Basel
Basel, Switzerland
Sponsors and Collaborators
Ipsen
Investigators
Study Director: Philipp Hoffmanns, MD, PhD, MBA Ipsen
  More Information

Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT01840449     History of Changes
Other Study ID Numbers: A-94-52030-240
First Submitted: April 23, 2013
First Posted: April 25, 2013
Last Update Posted: July 14, 2017
Last Verified: July 2017

Additional relevant MeSH terms:
Neuroendocrine Tumors
Carcinoid Tumor
Acromegaly
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Bone Diseases, Endocrine
Bone Diseases
Musculoskeletal Diseases
Hyperpituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Lanreotide
Angiopeptin
Somatostatin
Antineoplastic Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs