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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Ipsen
Sponsor:
Information provided by (Responsible Party):
Ipsen
ClinicalTrials.gov Identifier:
NCT02020967
First received: December 19, 2013
Last updated: November 3, 2014
Last verified: November 2014
  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 ] [ 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 ] [ 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 ] [ Designated as safety issue: No ]
  • Percentage of patients with microadenomas [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Percentage of patients with microadenomas, registered during MRI examination

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


Estimated Enrollment: 2000
Study Start Date: November 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (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
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

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

Locations
Russian Federation
Endocrinology Hospital at First Moscow State Medical University Recruiting
Moscow, Russian Federation, 119435
Moscow Board of Health Endocrinology Dispensary Recruiting
Moscow, Russian Federation, 119034
Sponsors and Collaborators
Ipsen
Investigators
Study Director: Elena Poznyakova, MD Ipsen
  More Information

No publications provided

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 3, 2014
Health Authority: Russia: Ethics Committee

Additional relevant MeSH terms:
Acromegaly
Bone Diseases
Bone Diseases, Endocrine
Brain Diseases
Central Nervous System Diseases
Endocrine System Diseases
Hyperpituitarism
Hypothalamic Diseases
Musculoskeletal Diseases
Nervous System Diseases
Pituitary Diseases

ClinicalTrials.gov processed this record on November 23, 2014