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Programme of Acromegaly Screening in Patients With Associated Somatic Disorders (ACROSCREEN)

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ClinicalTrials.gov Identifier: NCT02020967
Recruitment Status : Completed
First Posted : December 25, 2013
Last Update Posted : January 11, 2019
Sponsor:
Information provided by (Responsible Party):
Ipsen

Study Description
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Brief Summary:
The primary objective of the protocol is to define percentage of patients with acromegaly in relation to the total number of screened patients with confirmed clinically significant set of associated somatic disorders with the help of laboratory (Insulin-like Growth Factor I, Growth Hormone, Oral Glucose-Tolerance Test [IGF-1, GH, OGTT]) and instrumental examination methods (Magnetic Resonance Imaging [MRI]).

Condition or disease Intervention/treatment
Acromegaly Other: Non-interventional cross-sectional survey

Study Design
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Study Type : Observational
Actual Enrollment : 367 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Programme of Acromegaly Screening in Patients With Associated Somatic Disorders, Who Are Observed at the Moscow Board of Health Endocrinology Dispensary and Endocrinology Hospital at First Moscow State Medical University for the Purpose of Early Identification of the Disease.
Study Start Date : November 2013
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

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Groups and Cohorts
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Group/Cohort Intervention/treatment
Acromegaly patients Other: Non-interventional cross-sectional survey
This is a survey which does not involve any intervention into routine clinical practice, including the use of any investigational therapy or special examination methods.


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of patients with acromegaly [ Time Frame: 1 year and 7 months ]
    Percentage of patients with acromegaly in relation to the total amount of screened patients with confirmed clinically significant set of associated somatic disorders with the help of laboratory (IGF-1, GH, OGTT) and instrumental examination methods (MRI).


Secondary Outcome Measures :
  1. Number of patients diagnosed with acromegaly [ Time Frame: 1 year and 7 months ]
    Number of patients diagnosed with acromegaly with the help of laboratory (IGF-1, GH, OGTT) and instrumental examination methods (MRI)

  2. Demographic data of patients with confirmed clinically significant set of associated somatic disorders (age, sex); [ Time Frame: 1 year and 7 months ]
  3. Percentage of patients with microadenomas [ Time Frame: 1 year and 7 months ]
    Percentage of patients with microadenomas, registered during MRI examination

  4. Percentage of patients with macroadenomas [ Time Frame: 1 year and 7 months ]
    Percentage of patients with macroadenomas, registered during MRI examination


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with somatic disorders associated with acromegaly, who are observed at the Moscow Board of Health Endocrinology dispensary and Endocrinology Hospital at First Moscow State Medical University
Criteria

Inclusion Criteria:

  • Men and women aged 18 years and above with associated somatic disorders observed at the Moscow Endocrinology dispensary or Endocrinology Hospital at First Moscow State Medical University
  • Patients who signed the Informed Consent Form for participation in the survey before collection of any information.

Exclusion Criteria:

  • Patient already diagnosed with acromegaly
  • Patient's refusal to participate in the survey.
Contacts and Locations
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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): NCT02020967


Locations
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Russian Federation
Moscow Board of Health Endocrinology Dispensary
Moscow, Russian Federation, 119034
Endocrinology Hospital at First Moscow State Medical University
Moscow, Russian Federation, 119435
Sponsors and Collaborators
Ipsen
Investigators
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Study Director: Ipsen Medical Director Ipsen
More Information
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Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT02020967    
Other Study ID Numbers: A-38-52030-280
First Posted: December 25, 2013    Key Record Dates
Last Update Posted: January 11, 2019
Last Verified: January 2019
Additional relevant MeSH terms:
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Acromegaly
Bone Diseases, Endocrine
Bone Diseases
Musculoskeletal Diseases
Hyperpituitarism
Pituitary Diseases
 Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases