Neuroendocrine Tumors Clinical Trial
— SYMNETOfficial title:
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
NCT number | NCT01234168 |
Other study ID # | 8-79-52030-736 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | October 2010 |
Est. completion date | December 2012 |
Verified date | November 2020 |
Source | Ipsen |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 340 |
Est. completion date | December 2012 |
Est. primary completion date | December 2012 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Out-patients 18 years of age and older, who have agreed to participate in the study - Diagnosed with a Neuroendocrine tumour (NET) and receiving treatment with Somatuline Autogel Exclusion Criteria: - 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). |
Country | Name | City | State |
---|---|---|---|
Czechia | Teaching Hospital Brno Bohunice | Brno | |
Czechia | University Hospital Hradec Kralove | Hradec Kralove | |
Czechia | Hospital Pardubice | Pardubice | |
Czechia | Teaching Hospital | Plzen | |
Czechia | Charles University | Praha | |
Czechia | Teaching Hospital Na Bulovce | Praha | |
France | CHU Angers | Angers | |
France | Hôpital Avicenne | Bobigny | |
France | Hôpital Saint André | Bordeaux | |
France | CHU Trousseau | Chambray Les Tours | |
France | Hôpital Beaujon | Clichy | |
France | CHU Michallon | Grenoble | |
France | Hôpital Edouard Herriot | Lyon | |
France | CHU Timone | Marseille | |
France | Hôpital Archet 2 | Nice | |
France | Hôpital du Haut Leveque | Pessac | |
France | Hôpital Robert Debré | Reims | |
France | CHU St Etienne | Saint Priest | |
France | Hôpital Rangueil | Toulouse | |
France | Institut Gustave-Roussy | Villejuif | |
Hungary | Semmelweis University | Budapest | |
Hungary | Karádi-Nagy Bt. | Pécs | |
Israel | Hadasit Medical Research | Jerusalem | |
Italy | Ospedale Regina Apostolorum | Albano Laziale | |
Italy | Ospedale Pesenti Fenaroli | Alzano Lombardo | |
Italy | Ospedale Civile | Castelfranco Veneto | |
Italy | Università degli Studi di Chieti | Chieti | |
Italy | Istituti Ospedalieri di Cremona | Cremona | |
Italy | Azienda Ospedaliera-Universitaria Policlinico | Modena | |
Italy | U.O.C. Malattie dell'Apparato Digerente e del Fegato | Roma | |
Italy | Unità di Endocrinologia Istituti Fisioterapici Ospitalieri | Roma | |
Italy | Casa Sollievo della Sofferenza | San Giovanni Rotondo | |
Italy | Istituto Oncologico del Mediterraneo | Viagrande | |
Poland | Szpital Uniwersytecki im. A. Jurasza | Bydgoszcz | |
Poland | Slaskiego Uniwersytetu Medycznego | Katowice | |
Poland | Szpital Uniwersytecki w Krakowie | Krakow | |
Poland | Szpital Uniwersytecki w Lodzi | Lodz | |
Poland | Prywatna Praktyka Lekarska | Olsztyn | |
Poland | Specjalistyczny Gabinet Lekarski | Poznan | |
Poland | Samodzielny Publiczny Szpital Kliniczny Nr 1 | Szczecin | |
Poland | Niepubliczny Zaklad Opieki Zdrowotnej | Warszawa | |
Poland | Samodzielny Publiczny Centralny Szpital Kliniczny w Warszawie | Warszawa | |
Poland | Wojskowy Instytut Medyczny | Warszawa | |
Spain | Hospital De Cruces | Barakaldo | |
Spain | Hospital Universitari de Bellvitge | Barcelona | |
Spain | Hospital General Reina Sofia | Cordoba | |
Spain | Hospital Clinico Universitario de Santiago | La Coruña | |
Spain | Hospital Clinico San Carlos | Madrid | |
Spain | Hospital Xeral Cies de Vigo | Pontevedra | |
Spain | Hospital Virgen Macarena | Sevilla | |
Spain | Hospital Universitario Miguel Servet | Zaragoza | |
United Kingdom | University Hospital of Wales | Cardiff | |
United Kingdom | University Hospital | Coventry | |
United Kingdom | University Hospital Aintree | Liverpool | |
United Kingdom | Royal Free Hospital | London | |
United Kingdom | Chrisite Hospital Institute | Manchester | |
United Kingdom | Freeman Hospital | Newcastle upon Tyne |
Lead Sponsor | Collaborator |
---|---|
Ipsen |
Czechia, France, Hungary, Israel, Italy, Poland, Spain, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Subject's overall satisfaction regarding control of diarrhea | Use of questionnaires to assess patient satisfaction (Likert scale). | Day of survey | |
Secondary | Impact on daily activities of the clinical manifestations of diarrhea | Use of questionnaires to assess symptom severity and impact on patient's daily activities (CGI-S). | Day of survey |
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