ACROSCREEN: Programme of Acromegaly Screening in Patients With Associated Somatic Disorders

• Sponsor: Ipsen (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02020967
• Collaborator: (none)
• Enrollment: 367
• Locations: 2
• Actual Duration (Months): 21.3
• Patients Per Site: 183.5
• Patients Per Site Per Month: 8.6

Study Details

Study Description

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]).

Condition or Disease	Intervention/Treatment	Phase
Acromegaly	Other: Non-interventional cross-sectional survey

Study Design

• Study Type: Observational
• Actual Enrollment: 367 participants
• Observational Model: Cohort
• Time Perspective: Cross-Sectional
• 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.
• Actual Study Start Date: Dec 5, 2013
• Actual Primary Completion Date: Sep 15, 2015
• Actual Study Completion Date: Sep 15, 2015

Arms and Interventions

Arm	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.

Outcome Measures

Primary Outcome Measures

1. 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

1. 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).

2. 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.

3. 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.

4. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Moscow Board of Health Endocrinology Dispensary	Moscow		Russian Federation	119034
2	Endocrinology Hospital at First Moscow State Medical University	Moscow		Russian Federation	119435

Sponsors and Collaborators

• Ipsen

Investigators

• Study Director: Ipsen Medical Director, Ipsen

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ipsen
• ClinicalTrials.gov Identifier: NCT02020967
• Other Study ID Numbers: A-38-52030-280
• First Posted: Dec 25, 2013
• Last Update Posted: May 26, 2021
• Last Verified: May 1, 2021

• Additional relevant MeSH terms: Acromegaly

Study Results

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 Detail	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.

Arm/Group Title	All Participants
Arm/Group Description	Participants did not receive any investigational therapy or special examination methods. Participants screening was implemented in the following stages: Questioning stage: Participant's and Investigator's questionnaires. Based on the outcome of this stage, participants proceeded to the stage of examination to confirm acromegaly using biochemical assays. Stage of examination: Insulin-like growth factor 1 (IGF-1) level was measured. In case of increased IGF-1 level, growth hormone (GH) test before and after oral glucose tolerance test (OGTT) was conducted. If acromegaly was confirmed, pituitary magnetic resonance imaging (MRI) with contrast was made.
Period Title: Overall Study
STARTED	367
Examined Participants	329
COMPLETED	316
NOT COMPLETED	51

Baseline Characteristics

Arm/Group Title	Acromegaly Diagnosed	No Acromegaly Diagnosed	Total
Arm/Group Description	Participants did not receive any investigational therapy or special examination methods. Participants were diagnosed with acromegaly by biochemical assays.	Participants did not receive any investigational therapy or special examination methods. Participants were not diagnosed with acromegaly.	Total of all reporting groups
Overall Participants	9	320	329
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	58.1 (8.22)	58.0 (13.11)	58.0 (12.99)
Sex: Female, Male (Count of Participants)
Female	7 77.8%	268 83.8%	275 83.6%
Male	2 22.2%	52 16.3%	54 16.4%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants Diagnosed With Acromegaly
Description	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

Outcome Measure Data

Analysis Population Description

The Examined population included all participants for whom blood samples were taken for the biochemical assays to diagnose acromegaly.

Arm/Group Title	All Participants
Arm/Group Description	Participants did not receive any investigational therapy or special examination methods. Participants screening was implemented in the following stages: Questioning stage: Participant's and Investigator's questionnaires. Based on the outcome of this stage, participants proceeded to the stage of examination to confirm acromegaly using biochemical assays. Stage of examination: IGF-1 level was measured. In case of increased IGF-1 level, GH test before and after OGTT was conducted. If acromegaly was confirmed, pituitary MRI with contrast was made.
Measure Participants	329
Biochemical assays	5.8 64.4%
Pituitary MRI	2.4 26.7%

2. Secondary Outcome

Title	Number of Participants Diagnosed With Acromegaly Using Biochemical Assays (IGF-1, GH, OGTT) and Instrumental Examination Methods (MRI)
Description	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).
Time Frame	Participants were screened over approximately 21 months

Outcome Measure Data

Analysis Population Description

The Examined population included all participants for whom blood samples were taken for the biochemical assays to diagnose acromegaly.

Arm/Group Title	All Participants
Arm/Group Description	Participants did not receive any investigational therapy or special examination methods. Participants screening was implemented in the following stages: Questioning stage: Participant's and Investigator's questionnaires. Based on the outcome of this stage, participants proceeded to the stage of examination to confirm acromegaly using biochemical assays. Stage of examination: IGF-1 level was measured. In case of increased IGF-1 level, GH test before and after OGTT was conducted. If acromegaly was confirmed, pituitary MRI with contrast was made.
Measure Participants	329
Biochemical assays	19 211.1%
Pituitary MRI	8 88.9%

3. Secondary Outcome

Title	Percentage of Participants With Associated Concurrent Somatic Disorders
Description	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.
Time Frame	At baseline (Day 1)

Outcome Measure Data

Analysis Population Description

The Examined population included all participants for whom blood samples were taken for the biochemical assays to diagnose acromegaly.

Arm/Group Title	Acromegaly Diagnosed	No Acromegaly Diagnosed
Arm/Group Description	Participants did not receive any investigational therapy or special examination methods. Participants were diagnosed with acromegaly by biochemical assays.	Participants did not receive any investigational therapy or special examination methods. Participants were not diagnosed with acromegaly.
Measure Participants	9	320
Lips enlargement	22.2 246.7%	3.8 1.2%
Typical change of appearance and enlargement of limbs	100.0 1111.1%	56.9 17.8%
Headache	100.0 1111.1%	71.9 22.5%
Dyspnoea, decrease of working capacity	55.6 617.8%	80.9 25.3%

4. Secondary Outcome

Title	Percentage of Participants With Microadenomas and Macroadenomas
Description	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.
Time Frame	Participants were screened over approximately 21 months

Outcome Measure Data

Analysis Population Description

The Examined population included all participants for whom blood samples were taken for the biochemical assays to diagnose acromegaly.

Arm/Group Title	All Participants
Arm/Group Description	Participants did not receive any investigational therapy or special examination methods. Participants screening was implemented in the following stages: Questioning stage: Participant's and Investigator's questionnaires. Based on the outcome of this stage, participants proceeded to the stage of examination to confirm acromegaly using biochemical assays. Stage of examination: IGF-1 level was measured. In case of increased IGF-1 level, GH test before and after OGTT was conducted. If acromegaly was confirmed, pituitary MRI with contrast was made.
Measure Participants	329
Pituitary MRI performed: Microadenoma (<= 10 mm)	0.3 3.3%
Pituitary MRI performed: Macroadenoma (>10 mm)	2.1 23.3%
Pituitary MRI performed: No adenoma detected	2.7 30%
No pituitary MRI performed	94.8 1053.3%

5. Secondary Outcome

Title	Percentage of Participants With the Most Pathognomonic Subjective and Objective Signs for Tracing Acromegaly
Description	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.
Time Frame	Participants were screened over approximately 21 months

Outcome Measure Data

Analysis Population Description

The Examined population included all participants for whom blood samples were taken for the biochemical assays to diagnose acromegaly.

Arm/Group Title	Acromegaly Diagnosed	No Acromegaly Diagnosed
Arm/Group Description	Participants did not receive any investigational therapy or special examination methods. Participants were diagnosed with acromegaly by biochemical assays.	Participants did not receive any investigational therapy or special examination methods. Participants were not diagnosed with acromegaly.
Measure Participants	9	320
Logistic regression: Acromegaly	0 0%	0 0%
Logistic regression: No acromegaly	2.74 30.4%	97.26 30.4%
Canonical discriminant analysis: Acromegaly	1.52 16.9%	10.94 3.4%
Canonical discriminant analysis: No acromegaly	1.22 13.6%	86.32 27%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	All Participants, No Acromegaly Diagnosed
	Comments	Predictor variable: Lips enlargement
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0196
	Comments
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	7.34
	Confidence Interval	(2-Sided) 95%; 1.38 to 39.11
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Arm/Group Title	All Participants
Arm/Group Description	Participants did not receive any investigational therapy or special examination methods. Participants were involved in the survey focused on early acromegaly diagnosis.
All Cause Mortality
	All Participants
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	All Participants
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)
Other (Not Including Serious) Adverse Events
	All Participants
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.