Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2026-03-08 @ 11:02 PM
Study NCT ID:
NCT01471405
Status:
COMPLETED
Last Update Posted:
2019-01-11
First Post:
2011-11-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
One Year Follow-up of Study 2-79-52030-207 (PRIMARYS) in Acromegalic Patients With Macroadenoma
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': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-10', 'studyFirstSubmitDate': '2011-11-10', 'studyFirstSubmitQcDate': '2011-11-14', 'lastUpdatePostDateStruct': {'date': '2019-01-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-11-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of patients maintained on medical treatment with lanreotide Autogel', 'timeFrame': '1 year'}, {'measure': 'Proportion of patients receiving other medical treatments', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'Proportion of patients with at least one pituitary surgery', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Acromegaly']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://clinicaltrials.gov/ct2/show/NCT00690898?term=2-79-52030-207&rank=1', 'label': '2-79-52030-207 (NCT00690898)'}]}, 'descriptionModule': {'briefSummary': 'This non-interventional retrospective study aims to describe the therapeutic procedures and modalities received by patients and the correlation to hormone status, during a one year follow up from completion of the 2-79-52030-207 study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Outpatients', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Completed the 2-79-52030-207 study and received 12 injections of lanreotide Autogel 120 mg, regardless of efficacy at the end of this period.\n* Subject or in case of subject's death next of kin having given their written informed consent prior to collection of the data by the sponsor (if locally required)"}, 'identificationModule': {'nctId': 'NCT01471405', 'briefTitle': 'One Year Follow-up of Study 2-79-52030-207 (PRIMARYS) in Acromegalic Patients With Macroadenoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ipsen'}, 'officialTitle': 'Retrospective Non-interventional Study Evaluating Treatment Adaption During a One Year Follow-up After Completion of the 2-79-52030-207 Study in a Group of Acromegalic Patients With Macroadenoma Who Received 12 Injections of Lanreotide Autogel® 120 mg', 'orgStudyIdInfo': {'id': '8-79-52030-742'}}, 'contactsLocationsModule': {'locations': [{'city': 'Prague', 'country': 'Czechia', 'facility': 'III. Interní klinika Karlova Univerzita', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '76230', 'city': 'Bois-Guillaume', 'country': 'France', 'facility': 'CHU de Rouen', 'geoPoint': {'lat': 49.4602, 'lon': 1.12219}}, {'city': 'Bron', 'country': 'France', 'facility': "Groupement hôspitalier est Federation d'endocrinologie.", 'geoPoint': {'lat': 45.73865, 'lon': 4.91303}}, {'city': 'Grenoble', 'country': 'France', 'facility': 'CHU Michallon', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'city': 'Lille', 'country': 'France', 'facility': 'Hôpital Claude Huriez', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'city': 'Marseille', 'country': 'France', 'facility': 'CHU Timone', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Bicêtre', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Pessac', 'country': 'France', 'facility': 'Hôpital Haut Leveque', 'geoPoint': {'lat': 44.80565, 'lon': -0.6324}}, {'city': 'Reims', 'country': 'France', 'facility': 'CHU de Reims', 'geoPoint': {'lat': 49.26526, 'lon': 4.02853}}, {'city': 'Toulouse', 'country': 'France', 'facility': 'Hôpital Larrey', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'city': 'Essen', 'country': 'Germany', 'facility': 'Universität Duisburg-Essen', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'city': 'Frankfurt', 'country': 'Germany', 'facility': 'Klinikum der Johann Wolfgang, Goethe-Universität', 'geoPoint': {'lat': 49.68333, 'lon': 10.53333}}, {'city': 'Napoli', 'country': 'Italy', 'facility': 'Università Federico II di Napoli', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}, {'city': 'Roma', 'country': 'Italy', 'facility': 'Università Cattolica del Sacro Cuore', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'İstanbul Universitesi, Cerrahpaşa Tıp Fakültesi', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}, {'city': 'Aberdeen', 'country': 'United Kingdom', 'facility': 'Aberdeen Royal Infirmary', 'geoPoint': {'lat': 57.14369, 'lon': -2.09814}}, {'city': 'Manchester', 'country': 'United Kingdom', 'facility': 'Christie Hospital', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}, {'city': 'Plymouth', 'country': 'United Kingdom', 'facility': 'Derriford Hospital', 'geoPoint': {'lat': 50.37153, 'lon': -4.14305}}], 'overallOfficials': [{'name': 'Ipsen Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ipsen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ipsen', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}