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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ipsen
ClinicalTrials.gov Identifier:
NCT02020967
First received: December 19, 2013
Last updated: November 30, 2015
Last verified: November 2015
  Purpose
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 Intervention
Acromegaly
Other: Non-interventional cross-sectional survey

Study Type: Observational
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by Ipsen:

Primary Outcome Measures:
  • Percentage of patients with acromegaly [ Time Frame: 1 year and 7 months ] [ Designated as safety issue: No ]
    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:
  • Number of patients diagnosed with acromegaly [ Time Frame: 1 year and 7 months ] [ Designated as safety issue: No ]
    Number of patients diagnosed with acromegaly with the help of laboratory (IGF-1, GH, OGTT) and instrumental examination methods (MRI)

  • Demographic data of patients with confirmed clinically significant set of associated somatic disorders (age, sex); [ Time Frame: 1 year and 7 months ] [ Designated as safety issue: No ]
  • Percentage of patients with microadenomas [ Time Frame: 1 year and 7 months ] [ Designated as safety issue: No ]
    Percentage of patients with microadenomas, registered during MRI examination

  • Percentage of patients with macroadenomas [ Time Frame: 1 year and 7 months ] [ Designated as safety issue: No ]
    Percentage of patients with macroadenomas, registered during MRI examination


Enrollment: 367
Study Start Date: November 2013
Study Completion Date: September 2015
Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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
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: NCT02020967

Locations
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
Study Director: Elena Poznyakova, MD Ipsen
  More Information

Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT02020967     History of Changes
Other Study ID Numbers: A-38-52030-280 
Study First Received: December 19, 2013
Last Updated: November 30, 2015
Health Authority: Russia: Ethics Committee

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on August 25, 2016