Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2026-02-25 @ 2:35 AM
Study NCT ID:
NCT02231593
Status:
COMPLETED
Last Update Posted:
2020-03-31
First Post:
2014-09-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SAGIT for Classification of Patients With Acromegaly in Clinical Practice
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 71}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-30', 'studyFirstSubmitDate': '2014-09-02', 'studyFirstSubmitQcDate': '2014-09-02', 'lastUpdatePostDateStruct': {'date': '2020-03-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-09-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of acromegaly patients classified using SAGIT', 'timeFrame': '8 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Acromegaly']}, 'referencesModule': {'references': [{'pmid': '26377024', 'type': 'DERIVED', 'citation': 'Giustina A, Bevan JS, Bronstein MD, Casanueva FF, Chanson P, Petersenn S, Thanh XM, Sert C, Houchard A, Guillemin I, Melmed S; SAGIT Investigator Group. SAGIT(R): clinician-reported outcome instrument for managing acromegaly in clinical practice--development and results from a pilot study. Pituitary. 2016 Feb;19(1):39-49. doi: 10.1007/s11102-015-0681-2.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this pilot study is to test SAGIT (Signs and symptoms - Associated comorbidities - GH concentration level - IGF-1 - Tumour). SAGIT is a Clinician-Reported Outcomes (ClinROs) tool developed to describe patients with acromegaly. This study will determine the potential use of a finalised operational version for patient classification in clinical practice and studies.\n\nIn addition, this study intends to carry out a qualitative evaluation of the acceptability of SAGIT by the practicing endocrinologist in terms of relevance, ease of use, applicability and usefulness of the tool in practice.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Acromegaly patients registered with endocrinologists (hospital-based or outpatient clinics)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female aged 18 years-old or above\n* Patient with diagnosis of acromegaly with the presence of pituitary adenoma, elevated IGF-1 and lack of serum GH suppression after oral glucose tolerance test (OGTT)\n* Controlled/stable, active and treatment naïve patients.\n* Patient with the cognitive and linguistic capacities to understand the information letter of the study\n* Patient who signed informed consent\n\nExclusion Criteria:\n\n* History of non-compliance or inability to reliably receive treatment in the foreseeable future\n* Gaps in treatment of greater than 1 month within the 12 months prior to study entry'}, 'identificationModule': {'nctId': 'NCT02231593', 'acronym': 'SAGIT Pilot', 'briefTitle': 'SAGIT for Classification of Patients With Acromegaly in Clinical Practice', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ipsen'}, 'officialTitle': 'Pilot Testing of SAGIT in Patients With Acromegaly in Clinical Practice', 'orgStudyIdInfo': {'id': '8-79-52030-257'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Acromegalic patients', 'interventionNames': ['Other: SAGIT']}], 'interventions': [{'name': 'SAGIT', 'type': 'OTHER', 'description': 'SAGIT is a Clinician-Reported Outcomes (ClinROs) tool', 'armGroupLabels': ['Acromegalic patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Cedars-Sinai Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'NW Pituitary Center and Neurological Surgery', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '31270-901', 'city': 'Belo Horizonte', 'country': 'Brazil', 'facility': 'Federal University of Minas Gerais', 'geoPoint': {'lat': -19.92083, 'lon': -43.93778}}, {'zip': '80210070', 'city': 'Curitiba', 'country': 'Brazil', 'facility': 'Private practice', 'geoPoint': {'lat': -25.42778, 'lon': -49.27306}}, {'zip': '04143020', 'city': 'Saúde', 'country': 'Brazil', 'facility': 'Private practice', 'geoPoint': {'lat': -10.94111, 'lon': -40.41889}}, {'zip': '01246903', 'city': 'São Paulo', 'country': 'Brazil', 'facility': 'University of São Paulo Medical School', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'zip': '94275', 'city': 'Le Kremlin-Bicêtre', 'country': 'France', 'facility': 'CHU Bicetre', 'geoPoint': {'lat': 48.81471, 'lon': 2.36073}}, {'zip': '59000', 'city': 'Lille', 'country': 'France', 'facility': 'Hôpital Huriez, CHRU DE Lille', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'city': 'Rennes', 'country': 'France', 'facility': 'CHU Rennes Hôpital sud', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'zip': '12159', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Praxisgemeinschaft an der Kaisereiche, Wilhelm-Hauff-Straße 21', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '20246', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'Universitätsklinikum Hamburg-Eppendorf', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '80336', 'city': 'München', 'country': 'Germany', 'facility': 'LMU München', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'zip': '25128', 'city': 'Brescia', 'country': 'Italy', 'facility': 'Azienda Ospedaliera Spedali Civil di Brescia', 'geoPoint': {'lat': 45.53558, 'lon': 10.21472}}, {'zip': '25018', 'city': 'Montichiari', 'country': 'Italy', 'facility': 'Montichiari Hospital', 'geoPoint': {'lat': 45.41317, 'lon': 10.39799}}, {'zip': '10126', 'city': 'Torino', 'country': 'Italy', 'facility': 'Azienda Ospedaliera Città della Salute e della Scienza', 'geoPoint': {'lat': 44.88856, 'lon': 11.99138}}, {'zip': '10126', 'city': 'Torino', 'country': 'Italy', 'facility': 'San Giovanni Battista Hospital', 'geoPoint': {'lat': 44.88856, 'lon': 11.99138}}, {'zip': '15002', 'city': 'A Coruña', 'country': 'Spain', 'facility': 'Hospital Universitario La Coruna', 'geoPoint': {'lat': 43.37135, 'lon': -8.396}}, {'zip': '29010', 'city': 'Málaga', 'country': 'Spain', 'facility': 'Universitary Hospital Virgen de la Vitoria', 'geoPoint': {'lat': 36.72016, 'lon': -4.42034}}, {'zip': 'AB25 2ZN', 'city': 'Aberdeen', 'country': 'United Kingdom', 'facility': 'Aberdeen Royal Infirmary', 'geoPoint': {'lat': 57.14369, 'lon': -2.09814}}, {'zip': 'LS1 3EX', 'city': 'Leeds', 'country': 'United Kingdom', 'facility': 'Leeds General Infirmary', 'geoPoint': {'lat': 53.79648, 'lon': -1.54785}}, {'zip': 'PL6 8DH', 'city': 'Plymouth', 'country': 'United Kingdom', 'facility': 'Derriford Hospital', 'geoPoint': {'lat': 50.37153, 'lon': -4.14305}}], 'overallOfficials': [{'name': 'Ipsen Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ipsen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ipsen', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}