Programme of Acromegaly Screening in Patients With Associated Somatic Disorders

Study Overview
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Brief Summary
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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]).

Official Title
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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.

Conditions
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Acromegaly

Intervention / Treatment
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* Other: Non-interventional cross-sectional survey


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Acromegaly patients<br> | Other: Non-interventional cross-sectional survey<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Diagnosed With Acromegaly | 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). | Participants were screened over approximately 21 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Diagnosed With Acromegaly Using Biochemical Assays (IGF-1, GH, OGTT) and Instrumental Examination Methods (MRI) | 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). | Participants were screened over approximately 21 months | 
| Percentage of Participants With Associated Concurrent Somatic Disorders | 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. | At baseline (Day 1) | 
| Percentage of Participants With Microadenomas and Macroadenomas | 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. | Participants were screened over approximately 21 months | 
| Percentage of Participants With the Most Pathognomonic Subjective and Objective Signs for Tracing Acromegaly | 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. | Participants were screened over approximately 21 months |