Programme of Acromegaly Screening in Patients With Associated Somatic Disorders

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.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02020967

Acronym

ACROSCREEN

Enrollment

367

Registered

2013-12-25

Start date

2013-12-05

Completion date

2015-09-15

Last updated

2021-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acromegaly

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 \[MRI\]).

Interventions

OTHERNon-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.

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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).
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 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 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.

Countries

Russia

Participant flow

Recruitment details

This was a non-interventional cross-sectional survey conducted at 2 clinical sites in Russia between 05 December 2013 and 15 September 2015. This survey did not involve any intervention into routine clinical practice, including the use of any investigational therapy or special examination methods.

Pre-assignment details

Adults with somatic disorders associated with acromegaly who were observed as out-patients were eligible, and 367 participants were enrolled in the survey focused on early acromegaly diagnosis. Participants previously diagnosed with acromegaly were excluded.

Participants by arm

Arm	Count
Acromegaly Diagnosed Participants did not receive any investigational therapy or special examination methods. Participants were diagnosed with acromegaly by biochemical assays.	9
No Acromegaly Diagnosed Participants did not receive any investigational therapy or special examination methods. Participants were not diagnosed with acromegaly.	320
Total	329

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Withdrawal by Subject	51

Baseline characteristics

Characteristic	Acromegaly Diagnosed	No Acromegaly Diagnosed	Total
Age, Continuous	58.1 years STANDARD_DEVIATION 8.22	58.0 years STANDARD_DEVIATION 13.11	58.0 years STANDARD_DEVIATION 12.99
Sex: Female, Male Female	7 Participants	268 Participants	275 Participants
Sex: Female, Male Male	2 Participants	52 Participants	54 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	0 / 0
serious Total, serious adverse events	0 / 0

Outcome results

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).

Time frame: Participants were screened over approximately 21 months