Ignite Creation Date:
2025-12-25 @ 12:37 AM
Ignite Modification Date:
2026-03-22 @ 6:50 AM
Study NCT ID:
NCT02020967
Status:
COMPLETED
Last Update Posted:
2021-05-26
First Post:
2013-12-19
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Programme of Acromegaly Screening in Patients With Associated Somatic Disorders
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000172', 'term': 'Acromegaly'}], 'ancestors': [{'id': 'D001849', 'term': 'Bone Diseases, Endocrine'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D006964', 'term': 'Hyperpituitarism'}, {'id': 'D010900', 'term': 'Pituitary Diseases'}, {'id': 'D007027', 'term': 'Hypothalamic Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinical.trials@ipsen.com', 'phone': 'see email', 'title': 'Ipsen Medical Director', 'organization': 'Ipsen'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'All Participants', 'description': 'Participants did not receive any investigational therapy or special examination methods. Participants were involved in the survey focused on early acromegaly diagnosis.', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants Diagnosed With Acromegaly', 'denoms': [{'units': 'Participants', 'counts': [{'value': '329', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': "Participants did not receive any investigational therapy or special examination methods. Participants screening was implemented in the following stages:\n\n1. 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.\n2. 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."}], 'classes': [{'title': 'Biochemical assays', 'categories': [{'measurements': [{'value': '5.8', 'groupId': 'OG000'}]}]}, {'title': 'Pituitary MRI', 'categories': [{'measurements': [{'value': '2.4', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Participants were screened over approximately 21 months', '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).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Examined population included all participants for whom blood samples were taken for the biochemical assays to diagnose acromegaly.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Diagnosed With Acromegaly Using Biochemical Assays (IGF-1, GH, OGTT) and Instrumental Examination Methods (MRI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '329', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': "Participants did not receive any investigational therapy or special examination methods. Participants screening was implemented in the following stages:\n\n1. 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.\n2. 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."}], 'classes': [{'title': 'Biochemical assays', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}]}]}, {'title': 'Pituitary MRI', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Participants were screened over approximately 21 months', '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).', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Examined population included all participants for whom blood samples were taken for the biochemical assays to diagnose acromegaly.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Associated Concurrent Somatic Disorders', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '320', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Acromegaly Diagnosed', 'description': 'Participants did not receive any investigational therapy or special examination methods. Participants were diagnosed with acromegaly by biochemical assays.'}, {'id': 'OG001', 'title': 'No Acromegaly Diagnosed', 'description': 'Participants did not receive any investigational therapy or special examination methods. Participants were not diagnosed with acromegaly.'}], 'classes': [{'title': 'Lips enlargement', 'categories': [{'measurements': [{'value': '22.2', 'groupId': 'OG000'}, {'value': '3.8', 'groupId': 'OG001'}]}]}, {'title': 'Typical change of appearance and enlargement of limbs', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '56.9', 'groupId': 'OG001'}]}]}, {'title': 'Headache', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '71.9', 'groupId': 'OG001'}]}]}, {'title': 'Dyspnoea, decrease of working capacity', 'categories': [{'measurements': [{'value': '55.6', 'groupId': 'OG000'}, {'value': '80.9', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At baseline (Day 1)', '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.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Examined population included all participants for whom blood samples were taken for the biochemical assays to diagnose acromegaly.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Microadenomas and Macroadenomas', 'denoms': [{'units': 'Participants', 'counts': [{'value': '329', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': "Participants did not receive any investigational therapy or special examination methods. Participants screening was implemented in the following stages:\n\n1. 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.\n2. 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."}], 'classes': [{'title': 'Pituitary MRI performed: Microadenoma (<= 10 mm)', 'categories': [{'measurements': [{'value': '0.3', 'groupId': 'OG000'}]}]}, {'title': 'Pituitary MRI performed: Macroadenoma (>10 mm)', 'categories': [{'measurements': [{'value': '2.1', 'groupId': 'OG000'}]}]}, {'title': 'Pituitary MRI performed: No adenoma detected', 'categories': [{'measurements': [{'value': '2.7', 'groupId': 'OG000'}]}]}, {'title': 'No pituitary MRI performed', 'categories': [{'measurements': [{'value': '94.8', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Participants were screened over approximately 21 months', '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.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Examined population included all participants for whom blood samples were taken for the biochemical assays to diagnose acromegaly.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With the Most Pathognomonic Subjective and Objective Signs for Tracing Acromegaly', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '320', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Acromegaly Diagnosed', 'description': 'Participants did not receive any investigational therapy or special examination methods. Participants were diagnosed with acromegaly by biochemical assays.'}, {'id': 'OG001', 'title': 'No Acromegaly Diagnosed', 'description': 'Participants did not receive any investigational therapy or special examination methods. Participants were not diagnosed with acromegaly.'}], 'classes': [{'title': 'Logistic regression: Acromegaly', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Logistic regression: No acromegaly', 'categories': [{'measurements': [{'value': '2.74', 'groupId': 'OG000'}, {'value': '97.26', 'groupId': 'OG001'}]}]}, {'title': 'Canonical discriminant analysis: Acromegaly', 'categories': [{'measurements': [{'value': '1.52', 'groupId': 'OG000'}, {'value': '10.94', 'groupId': 'OG001'}]}]}, {'title': 'Canonical discriminant analysis: No acromegaly', 'categories': [{'measurements': [{'value': '1.22', 'groupId': 'OG000'}, {'value': '86.32', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0196', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.34', 'ciLowerLimit': '1.38', 'ciUpperLimit': '39.11', 'groupDescription': 'Predictor variable: Lips enlargement', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Participants were screened over approximately 21 months', '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.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Examined population included all participants for whom blood samples were taken for the biochemical assays to diagnose acromegaly.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'All Participants', 'description': "Participants did not receive any investigational therapy or special examination methods. Participants screening was implemented in the following stages:\n\n1. 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.\n2. 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."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '367'}]}, {'type': 'Examined Participants', 'achievements': [{'groupId': 'FG000', 'numSubjects': '329'}]}, {'type': 'COMPLETED', 'comment': 'Completed Participation in the Survey.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '316'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '51'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '51'}]}]}], 'recruitmentDetails': '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.', 'preAssignmentDetails': '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.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}, {'value': '320', 'groupId': 'BG001'}, {'value': '329', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Acromegaly Diagnosed', 'description': 'Participants did not receive any investigational therapy or special examination methods. Participants were diagnosed with acromegaly by biochemical assays.'}, {'id': 'BG001', 'title': 'No Acromegaly Diagnosed', 'description': 'Participants did not receive any investigational therapy or special examination methods. Participants were not diagnosed with acromegaly.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '58.1', 'spread': '8.22', 'groupId': 'BG000'}, {'value': '58.0', 'spread': '13.11', 'groupId': 'BG001'}, {'value': '58.0', 'spread': '12.99', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '268', 'groupId': 'BG001'}, {'value': '275', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The Examined population included all participants for whom blood samples were taken for the biochemical assays to diagnose acromegaly.'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 367}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-12-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2015-09-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-07', 'studyFirstSubmitDate': '2013-12-19', 'resultsFirstSubmitDate': '2021-04-07', 'studyFirstSubmitQcDate': '2013-12-19', 'lastUpdatePostDateStruct': {'date': '2021-05-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-04-07', 'studyFirstPostDateStruct': {'date': '2013-12-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-04-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-09-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Diagnosed With Acromegaly', 'timeFrame': 'Participants were screened over approximately 21 months', '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).'}], 'secondaryOutcomes': [{'measure': 'Number of Participants Diagnosed With Acromegaly Using Biochemical Assays (IGF-1, GH, OGTT) and Instrumental Examination Methods (MRI)', 'timeFrame': 'Participants were screened over approximately 21 months', '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).'}, {'measure': 'Percentage of Participants With Associated Concurrent Somatic Disorders', 'timeFrame': 'At baseline (Day 1)', '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.'}, {'measure': 'Percentage of Participants With Microadenomas and Macroadenomas', 'timeFrame': 'Participants were screened over approximately 21 months', '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.'}, {'measure': 'Percentage of Participants With the Most Pathognomonic Subjective and Objective Signs for Tracing Acromegaly', 'timeFrame': 'Participants were screened over approximately 21 months', '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.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Acromegaly']}, 'descriptionModule': {'briefSummary': '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\\]).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 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\n* Patients who signed the Informed Consent Form for participation in the survey before collection of any information.\n\nExclusion Criteria:\n\n* Patient already diagnosed with acromegaly\n* Patient's refusal to participate in the survey."}, 'identificationModule': {'nctId': 'NCT02020967', 'acronym': 'ACROSCREEN', 'briefTitle': 'Programme of Acromegaly Screening in Patients With Associated Somatic Disorders', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ipsen'}, 'officialTitle': '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.', 'orgStudyIdInfo': {'id': 'A-38-52030-280'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Acromegaly patients', 'interventionNames': ['Other: Non-interventional cross-sectional survey']}], 'interventions': [{'name': 'Non-interventional cross-sectional survey', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['Acromegaly patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '119034', 'city': 'Moscow', 'country': 'Russia', 'facility': 'Moscow Board of Health Endocrinology Dispensary', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '119435', 'city': 'Moscow', 'country': 'Russia', 'facility': 'Endocrinology Hospital at First Moscow State Medical University', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}], 'overallOfficials': [{'name': 'Ipsen Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ipsen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ipsen', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}