Programme of Acromegaly Screening in Patients With Associated Somatic Disorders

Acromegaly Clinical Trial

— ACROSCREEN  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02020967
• Other study ID #: A-38-52030-280
• Status: Completed
• Start date: December 5, 2013
• Est. completion date: September 15, 2015

Study information

• Verified date: May 2021
• Source: Ipsen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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]).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 367
• Est. completion date: September 15, 2015
• Est. primary completion date: September 15, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acromegaly

Intervention

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.

Locations

Country	Name	City	State
Russian Federation	Endocrinology Hospital at First Moscow State Medical University	Moscow
Russian Federation	Moscow Board of Health Endocrinology Dispensary	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
Ipsen

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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)
Secondary	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
Secondary	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