Programme of Acromegaly Screening in Patients With Associated Somatic Disorders

Completed

• Conditions: Acromegaly
• Interventions: Other: Non-interventional cross-sectional survey

• Registration Number: NCT02020967
• Lead Sponsor: Ipsen

Brief Summary

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 \[MRI\]).

Detailed Description

Not available

Study Timeline

• Study Start: 2013-12-05
• Study First Submitted: 2013-12-19
• Study First Submitted QC: 2013-12-19
• Study First Posted: 2013-12-25
• Primary Completion: 2015-09-15
• Study Completion: 2015-09-15
• Results First Submitted: 2021-04-07
• Results First Submitted QC: 2021-04-07
• Results First Posted: 2021-04-28
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-07
• Last Update Posted: 2021-05-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 367

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Acromegaly patients	Non-interventional cross-sectional survey	-

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Diagnosed With Acromegaly	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 Outcome Measures

Name	Time	Method
Percentage of Participants With Microadenomas and Macroadenomas	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.
Percentage of Participants With Associated Concurrent Somatic Disorders	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.
Percentage of Participants With the Most Pathognomonic Subjective and Objective Signs for Tracing Acromegaly	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.
Number of Participants Diagnosed With Acromegaly Using Biochemical Assays (IGF-1, GH, OGTT) and Instrumental Examination Methods (MRI)	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).

Trial Locations

Locations (2)

Endocrinology Hospital at First Moscow State Medical University; 🇷🇺 Moscow, Russian Federation

Moscow Board of Health Endocrinology Dispensary; 🇷🇺 Moscow, Russian Federation