Somatuline Predictive Factors in Acromegaly and NET (SOPRANo)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Ipsen
Sponsor:
Information provided by (Responsible Party):
Ipsen
ClinicalTrials.gov Identifier:
NCT01840449
First received: April 23, 2013
Last updated: September 30, 2014
Last verified: September 2014
  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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 152
Study Start Date: June 2012
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01840449

Contacts
Contact: Ipsen Recruitment Enquiries clinical.trials@ipsen.com

Locations
Austria
University Hospital of Vienna Recruiting
Vienna, Austria
Germany
ENDOC Recruiting
Hamburg, Germany, 20357
Sponsors and Collaborators
Ipsen
Investigators
Study Director: Philipp Hoffmanns, MD, PhD, MBA Ipsen
  More Information

No publications provided

Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT01840449     History of Changes
Other Study ID Numbers: A-94-52030-240
Study First Received: April 23, 2013
Last Updated: September 30, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Austria: Agency for Health and Food Safety
Switzerland: Swissmedic

Additional relevant MeSH terms:
Acromegaly
Neuroendocrine Tumors
Bone Diseases
Bone Diseases, Endocrine
Brain Diseases
Central Nervous System Diseases
Endocrine System Diseases
Hyperpituitarism
Hypothalamic Diseases
Musculoskeletal Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Nervous System Diseases
Neuroectodermal Tumors
Pituitary Diseases
Angiopeptin
Lanreotide
Antineoplastic Agents
Cardiovascular Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014