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

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.

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]).

Study Overview

• Status: Completed
• Conditions: Acromegaly
• Intervention / Treatment: Other: Non-interventional cross-sectional survey

• Study Type: Observational
• Enrollment (Actual): 367

Contacts and Locations

Study Locations

• Russian Federation
  • Moscow, Russian Federation, 119034
    • Moscow Board of Health Endocrinology Dispensary
  • Moscow, Russian Federation, 119435
    • Endocrinology Hospital at First Moscow State Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ipsen

Study record dates

Study Major Dates

• Study Start (Actual): December 5, 2013
• Primary Completion (Actual): September 15, 2015
• Study Completion (Actual): September 15, 2015

Study Registration Dates

• First Submitted: December 19, 2013
• First Submitted That Met QC Criteria: December 19, 2013
• First Posted (Estimate): December 25, 2013

Study Record Updates

• Last Update Posted (Actual): May 26, 2021
• Last Update Submitted That Met QC Criteria: May 7, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases; Musculoskeletal Diseases; Hypothalamic Diseases; Bone Diseases; Bone Diseases, Endocrine; Hyperpituitarism; Pituitary Diseases; Acromegaly
• Other Study ID Numbers: A-38-52030-280