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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]).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acromegaly patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-interventional cross-sectional survey | Other | 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. |
| 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 |
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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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
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| Name | Affiliation | Role |
|---|---|---|
| Ipsen Medical Director | Ipsen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Moscow Board of Health Endocrinology Dispensary | Moscow | 119034 | Russia | |||
| Endocrinology Hospital at First Moscow State Medical University |
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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | All Participants | Participants did not receive any investigational therapy or special examination methods. Participants screening was implemented in the following stages:
|
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The Examined population included all participants for whom blood samples were taken for the biochemical assays to diagnose acromegaly.
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| ID | Title | Description |
|---|---|---|
| BG000 | Acromegaly Diagnosed | Participants did not receive any investigational therapy or special examination methods. Participants were diagnosed with acromegaly by biochemical assays. |
| BG001 | No Acromegaly Diagnosed |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | The Examined population included all participants for whom blood samples were taken for the biochemical assays to diagnose acromegaly. | Posted | Number | percentage of participants | Participants were screened over approximately 21 months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Participants | Participants did not receive any investigational therapy or special examination methods. Participants were involved in the survey focused on early acromegaly diagnosis. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ipsen Medical Director | Ipsen | see email | clinical.trials@ipsen.com |
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| ID | Term |
|---|---|
| D000172 | Acromegaly |
| ID | Term |
|---|---|
| D001849 | Bone Diseases, Endocrine |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D006964 | Hyperpituitarism |
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| 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 |
| Moscow |
| 119435 |
| Russia |
Participants did not receive any investigational therapy or special examination methods. Participants were not diagnosed with acromegaly.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| 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). | The Examined population included all participants for whom blood samples were taken for the biochemical assays to diagnose acromegaly. | Posted | Count of Participants | Participants | No | 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. | The Examined population included all participants for whom blood samples were taken for the biochemical assays to diagnose acromegaly. | Posted | Number | percentage of participants | 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. | The Examined population included all participants for whom blood samples were taken for the biochemical assays to diagnose acromegaly. | Posted | Number | percentage of participants | 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. | The Examined population included all participants for whom blood samples were taken for the biochemical assays to diagnose acromegaly. | Posted | Number | percentage of participants | Participants were screened over approximately 21 months |
|
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
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| D010900 |
| Pituitary Diseases |
| D007027 | Hypothalamic Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D004700 | Endocrine System Diseases |
| Headache |
|
| Dyspnoea, decrease of working capacity |
|
| Title | Measurements |
|---|---|
|
| No pituitary MRI performed |
|
| Canonical discriminant analysis: Acromegaly |
|
| Canonical discriminant analysis: No acromegaly |
|