Ignite Creation Date:
2025-12-24 @ 5:40 PM
Ignite Modification Date:
2025-12-28 @ 7:45 AM
Study NCT ID:
NCT01234168
Status:
COMPLETED
Last Update Posted:
2020-11-05
First Post:
2010-10-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Assess Neuroendocrine Tumour (NET) Patients Currently Treated by Somatuline Autogel for History of Carcinoid Syndrome Associated With Episodes of Diarrhea
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D020230', 'term': 'Serotonin Syndrome'}], 'ancestors': [{'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D064420', 'term': 'Drug-Related Side Effects and Adverse Reactions'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 340}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-04', 'studyFirstSubmitDate': '2010-10-20', 'studyFirstSubmitQcDate': '2010-11-03', 'lastUpdatePostDateStruct': {'date': '2020-11-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-11-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Subject's overall satisfaction regarding control of diarrhea", 'timeFrame': 'Day of survey', 'description': 'Use of questionnaires to assess patient satisfaction (Likert scale).'}], 'secondaryOutcomes': [{'measure': 'Impact on daily activities of the clinical manifestations of diarrhea', 'timeFrame': 'Day of survey', 'description': "Use of questionnaires to assess symptom severity and impact on patient's daily activities (CGI-S)."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Neuroendocrine Tumors', 'Carcinoid Syndrome']}, 'referencesModule': {'references': [{'pmid': '26917486', 'type': 'DERIVED', 'citation': 'Ruszniewski P, Valle JW, Lombard-Bohas C, Cuthbertson DJ, Perros P, Holubec L, Delle Fave G, Smith D, Niccoli P, Maisonobe P, Atlan P, Caplin ME; SYMNET study group. Patient-reported outcomes with lanreotide Autogel/Depot for carcinoid syndrome: An international observational study. Dig Liver Dis. 2016 May;48(5):552-558. doi: 10.1016/j.dld.2015.12.013. Epub 2016 Jan 15.'}]}, 'descriptionModule': {'briefSummary': "The purpose of the protocol is to to assess subject's overall satisfaction regarding control of diarrhea. The study aims to supplement results obtained through clinical trials with data obtained from a population of patients receiving treatment with Somatuline Autogel in routine practice."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Out-patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Out-patients 18 years of age and older, who have agreed to participate in the study\n* Diagnosed with a Neuroendocrine tumour (NET) and receiving treatment with Somatuline Autogel\n\nExclusion Criteria:\n\n* Subjects for whom there are reasons that may hinder the conduct of the study (patients who have difficulty expressing themselves or who are unable to complete the questionnaires, or with insufficient data in the their files will not be enrolled in the study).'}, 'identificationModule': {'nctId': 'NCT01234168', 'acronym': 'SYMNET', 'briefTitle': 'A Study to Assess Neuroendocrine Tumour (NET) Patients Currently Treated by Somatuline Autogel for History of Carcinoid Syndrome Associated With Episodes of Diarrhea', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ipsen'}, 'officialTitle': 'An International, Cross Sectional, Non-interventional, Study to Assess Neuroendocrine Tumour (NET) Patients Currently Treated by Somatuline Autogel for History of Carcinoid Syndrome Associated With Episodes of Diarrhea', 'orgStudyIdInfo': {'id': '8-79-52030-736'}}, 'contactsLocationsModule': {'locations': [{'city': 'Brno', 'country': 'Czechia', 'facility': 'Teaching Hospital Brno Bohunice', 'geoPoint': {'lat': 49.19522, 'lon': 16.60796}}, {'city': 'Hradec Králové', 'country': 'Czechia', 'facility': 'University Hospital Hradec Kralove', 'geoPoint': {'lat': 50.20923, 'lon': 15.83277}}, {'city': 'Pardubice', 'country': 'Czechia', 'facility': 'Hospital Pardubice', 'geoPoint': {'lat': 50.04075, 'lon': 15.77659}}, {'city': 'Pilsen', 'country': 'Czechia', 'facility': 'Teaching Hospital', 'geoPoint': {'lat': 49.74747, 'lon': 13.37759}}, {'city': 'Prague', 'country': 'Czechia', 'facility': 'Charles University', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'city': 'Prague', 'country': 'Czechia', 'facility': 'Teaching Hospital Na Bulovce', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '49933', 'city': 'Angers', 'country': 'France', 'facility': 'CHU Angers', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'zip': '93009', 'city': 'Bobigny', 'country': 'France', 'facility': 'Hôpital Avicenne', 'geoPoint': {'lat': 48.90982, 'lon': 2.45012}}, {'zip': '33075', 'city': 'Bordeaux', 'country': 'France', 'facility': 'Hôpital Saint André', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '37171', 'city': 'Chambray-lès-Tours', 'country': 'France', 'facility': 'CHU Trousseau', 'geoPoint': {'lat': 47.33537, 'lon': 0.70286}}, {'zip': '92118', 'city': 'Clichy', 'country': 'France', 'facility': 'Hôpital Beaujon', 'geoPoint': {'lat': 48.90018, 'lon': 2.30952}}, {'zip': '38043', 'city': 'Grenoble', 'country': 'France', 'facility': 'CHU Michallon', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'zip': '69437', 'city': 'Lyon', 'country': 'France', 'facility': 'Hôpital Edouard Herriot', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '13385', 'city': 'Marseille', 'country': 'France', 'facility': 'CHU Timone', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '06202', 'city': 'Nice', 'country': 'France', 'facility': 'Hôpital Archet 2', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'zip': '33604', 'city': 'Pessac', 'country': 'France', 'facility': 'Hôpital du Haut Leveque', 'geoPoint': {'lat': 44.80565, 'lon': -0.6324}}, {'zip': '51092', 'city': 'Reims', 'country': 'France', 'facility': 'Hôpital Robert Debré', 'geoPoint': {'lat': 49.26526, 'lon': 4.02853}}, {'zip': '42270', 'city': 'Saint-Priest', 'country': 'France', 'facility': 'CHU St Etienne', 'geoPoint': {'lat': 45.69651, 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'Castelfranco Veneto', 'country': 'Italy', 'facility': 'Ospedale Civile', 'geoPoint': {'lat': 45.67146, 'lon': 11.92755}}, {'city': 'Chieti', 'country': 'Italy', 'facility': 'Università degli Studi di Chieti', 'geoPoint': {'lat': 42.34827, 'lon': 14.16494}}, {'city': 'Cremona', 'country': 'Italy', 'facility': 'Istituti Ospedalieri di Cremona', 'geoPoint': {'lat': 45.13325, 'lon': 10.02129}}, {'city': 'Modena', 'country': 'Italy', 'facility': 'Azienda Ospedaliera-Universitaria Policlinico', 'geoPoint': {'lat': 44.64783, 'lon': 10.92539}}, {'city': 'Roma', 'country': 'Italy', 'facility': "U.O.C. Malattie dell'Apparato Digerente e del Fegato", 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'city': 'Roma', 'country': 'Italy', 'facility': 'Unità di Endocrinologia Istituti Fisioterapici Ospitalieri', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'city': 'San Giovanni Rotondo', 'country': 'Italy', 'facility': 'Casa Sollievo della Sofferenza', 'geoPoint': {'lat': 41.70643, 'lon': 15.7277}}, {'city': 'Viagrande', 'country': 'Italy', 'facility': 'Istituto Oncologico del Mediterraneo', 'geoPoint': {'lat': 37.61032, 'lon': 15.09794}}, {'city': 'Bydgoszcz', 'country': 'Poland', 'facility': 'Szpital Uniwersytecki im. A. Jurasza', 'geoPoint': {'lat': 53.1235, 'lon': 18.00762}}, {'city': 'Katowice', 'country': 'Poland', 'facility': 'Slaskiego Uniwersytetu Medycznego', 'geoPoint': {'lat': 50.2597, 'lon': 19.02173}}, {'city': 'Krakow', 'country': 'Poland', 'facility': 'Szpital Uniwersytecki w Krakowie', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'city': 'Lodz', 'country': 'Poland', 'facility': 'Szpital Uniwersytecki w Lodzi', 'geoPoint': {'lat': 51.77058, 'lon': 19.47395}}, {'city': 'Olsztyn', 'country': 'Poland', 'facility': 'Prywatna Praktyka Lekarska', 'geoPoint': {'lat': 53.78376, 'lon': 20.49272}}, {'city': 'Poznan', 'country': 'Poland', 'facility': 'Specjalistyczny Gabinet Lekarski', 'geoPoint': {'lat': 52.40692, 'lon': 16.92993}}, {'city': 'Szczecin', 'country': 'Poland', 'facility': 'Samodzielny Publiczny Szpital Kliniczny Nr 1', 'geoPoint': {'lat': 53.42894, 'lon': 14.55302}}, {'city': 'Warsaw', 'country': 'Poland', 'facility': 'Niepubliczny Zaklad Opieki Zdrowotnej', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'city': 'Warsaw', 'country': 'Poland', 'facility': 'Samodzielny Publiczny Centralny Szpital Kliniczny w Warszawie', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'city': 'Warsaw', 'country': 'Poland', 'facility': 'Wojskowy Instytut Medyczny', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'city': 'A Coruña', 'country': 'Spain', 'facility': 'Hospital Clinico Universitario de Santiago', 'geoPoint': {'lat': 43.37135, 'lon': -8.396}}, {'city': 'Barakaldo', 'country': 'Spain', 'facility': 'Hospital De Cruces', 'geoPoint': {'lat': 43.29639, 'lon': -2.98813}}, {'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Universitari de Bellvitge', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Córdoba', 'country': 'Spain', 'facility': 'Hospital General Reina Sofia', 'geoPoint': {'lat': 37.89155, 'lon': -4.77275}}, {'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Clinico San Carlos', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Pontevedra', 'country': 'Spain', 'facility': 'Hospital Xeral Cies de Vigo', 'geoPoint': {'lat': 42.431, 'lon': -8.64435}}, {'city': 'Seville', 'country': 'Spain', 'facility': 'Hospital Virgen Macarena', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'city': 'Zaragoza', 'country': 'Spain', 'facility': 'Hospital Universitario Miguel Servet', 'geoPoint': {'lat': 41.65606, 'lon': -0.87734}}, {'zip': 'CF14 4XN', 'city': 'Cardiff', 'country': 'United Kingdom', 'facility': 'University Hospital of Wales', 'geoPoint': {'lat': 51.48, 'lon': -3.18}}, {'zip': 'CV2 2DX', 'city': 'Coventry', 'country': 'United Kingdom', 'facility': 'University Hospital', 'geoPoint': {'lat': 52.40656, 'lon': -1.51217}}, {'zip': 'L9 7AL', 'city': 'Liverpool', 'country': 'United Kingdom', 'facility': 'University Hospital Aintree', 'geoPoint': {'lat': 53.41058, 'lon': -2.97794}}, {'city': 'London', 'country': 'United Kingdom', 'facility': 'Royal Free Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'M204BX', 'city': 'Manchester', 'country': 'United Kingdom', 'facility': 'Chrisite Hospital Institute', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}, {'zip': 'NE7 7DN', 'city': 'Newcastle upon Tyne', 'country': 'United Kingdom', 'facility': 'Freeman Hospital', 'geoPoint': {'lat': 54.97328, 'lon': -1.61396}}], 'overallOfficials': [{'name': 'Ipsen Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ipsen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ipsen', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}