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Completed

NCT Number: NCT02020967

Programme of Acromegaly Screening in Patients With Associated Somatic Disorders

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]).

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Endocrinology Hospital at First Moscow State Medical University, Moscow, Russia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Non-interventional cross-sectional survey

Other

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.

Primary outcomes

  1. Percentage of Participants Diagnosed With Acromegaly

    Time frame: Participants were screened over approximately 21 months

    Acromegaly is an acquired pathological condition related to excessive production of growth hormone and characterized by somatic disfigurement and multiple systemic manifestations. The percentage of participants with acromegaly was determined in participants with a confirmed clinically significant set of associated somatic disorders using biochemical assays (IGF-1, GH, OGTT) and instrumental examination methods (MRI).

Secondary outcomes

  1. Number of Participants Diagnosed With Acromegaly Using Biochemical Assays (IGF-1, GH, OGTT) and Instrumental Examination Methods (MRI)

    Time frame: Participants were screened over approximately 21 months

    Acromegaly is an acquired pathological condition related to excessive production of growth hormone and characterized by somatic disfigurement and multiple systemic manifestations. The number of participants with acromegaly was determined in participants with a confirmed clinically significant set of associated somatic disorders using biochemical assays (IGF-1, GH, OGTT) and instrumental examination methods (MRI).

  2. Percentage of Participants With Associated Concurrent Somatic Disorders

    Time frame: At baseline (Day 1)

    The percentage of participants with associated concurrent somatic disorders were reported in relation to confirmation of acromegaly diagnosis. Concurrent disorders were prior history of condition or diagnosis.

  3. Percentage of Participants With Microadenomas and Macroadenomas

    Time frame: Participants were screened over approximately 21 months

    Participants were counted as having a microadenomas or macroadenomas if they had at least one microadenoma or macroadenoma during the study. Microadenoma is a benign pituitary tumour size <=10 millimeter (mm) and macroadenoma is a benign pituitary tumour size >10 mm. The percentage of participants with microadenomas and macroadenomas registered during pituitary MRI examination were reported.

  4. Percentage of Participants With the Most Pathognomonic Subjective and Objective Signs for Tracing Acromegaly

    Time frame: Participants were screened over approximately 21 months

    Acromegaly diagnosed based on a clinically significant set of associated somatic disorders and was assessed by logistic regression and canonical discriminant analysis. The likelihood of acromegaly diagnosis, based on a clinically significant set of associated somatic disorders (predictors) was assessed by logistic regression and canonical discriminant analysis. To investigate the extent to which each of the somatic disorders poses a risk factor for acromegaly diagnosis, all predictor variables were entered into each analysis. The percentage of participants predicted to have acromegaly or not is presented for the logistic regression analysis and the canonical discriminant analysis.

Sponsors and collaborators

Lead sponsor

Ipsen

Industry

Registry information

Official study 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.

Acronym: ACROSCREEN

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Dec 25, 2013
Registry last updated
May 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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