A Study to Assess Neuroendocrine Tumour (NET) Patients Currently Treated by Somatuline Autogel for History of Carcinoid Syndrome Associated With Episodes of Diarrhea

Completed

• Conditions: Neuroendocrine Tumors; Carcinoid Syndrome

• Registration Number: NCT01234168
• Lead Sponsor: Ipsen

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2010-10-20
• Study First Submitted QC: 2010-11-03
• Study First Posted: 2010-11-04
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-04
• Last Update Posted: 2020-11-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 340

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Subject's overall satisfaction regarding control of diarrhea	Day of survey	Use of questionnaires to assess patient satisfaction (Likert scale).

Secondary Outcome Measures

Name	Time	Method
Impact on daily activities of the clinical manifestations of diarrhea	Day of survey	Use of questionnaires to assess symptom severity and impact on patient's daily activities (CGI-S).

Trial Locations

Locations (57)

Hospital Pardubice; 🇨🇿 Pardubice, Czechia

CHU Angers; 🇫🇷 Angers, France

Hôpital Saint André; 🇫🇷 Bordeaux, France

Teaching Hospital Brno Bohunice; 🇨🇿 Brno, Czechia

University Hospital Hradec Kralove; 🇨🇿 Hradec Kralove, Czechia

Teaching Hospital; 🇨🇿 Plzen, Czechia

Charles University; 🇨🇿 Praha, Czechia

Teaching Hospital Na Bulovce; 🇨🇿 Praha, Czechia

Hôpital Avicenne; 🇫🇷 Bobigny, France

Hôpital Robert Debré; 🇫🇷 Reims, France

Hôpital Edouard Herriot; 🇫🇷 Lyon, France

Hôpital Beaujon; 🇫🇷 Clichy, France

CHU Timone; 🇫🇷 Marseille, France

CHU Trousseau; 🇫🇷 Chambray Les Tours, France

CHU Michallon; 🇫🇷 Grenoble, France

Hôpital Archet 2; 🇫🇷 Nice, France

Hôpital du Haut Leveque; 🇫🇷 Pessac, France

CHU St Etienne; 🇫🇷 Saint Priest, France

Karádi-Nagy Bt.; 🇭🇺 Pécs, Hungary

Hôpital Rangueil; 🇫🇷 Toulouse, France

Institut Gustave-Roussy; 🇫🇷 Villejuif, France

Semmelweis University; 🇭🇺 Budapest, Hungary

Hadasit Medical Research; 🇮🇱 Jerusalem, Israel

Ospedale Regina Apostolorum; 🇮🇹 Albano Laziale, Italy

U.O.C. Malattie dell'Apparato Digerente e del Fegato; 🇮🇹 Roma, Italy

Ospedale Pesenti Fenaroli; 🇮🇹 Alzano Lombardo, Italy

Istituti Ospedalieri di Cremona; 🇮🇹 Cremona, Italy

Ospedale Civile; 🇮🇹 Castelfranco Veneto, Italy

Università degli Studi di Chieti; 🇮🇹 Chieti, Italy

Azienda Ospedaliera-Universitaria Policlinico; 🇮🇹 Modena, Italy

Unità di Endocrinologia Istituti Fisioterapici Ospitalieri; 🇮🇹 Roma, Italy

Casa Sollievo della Sofferenza; 🇮🇹 San Giovanni Rotondo, Italy

Szpital Uniwersytecki im. A. Jurasza; 🇵🇱 Bydgoszcz, Poland

Istituto Oncologico del Mediterraneo; 🇮🇹 Viagrande, Italy

Hospital Universitari de Bellvitge; 🇪🇸 Barcelona, Spain

Szpital Uniwersytecki w Lodzi; 🇵🇱 Lodz, Poland

Slaskiego Uniwersytetu Medycznego; 🇵🇱 Katowice, Poland

Szpital Uniwersytecki w Krakowie; 🇵🇱 Krakow, 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

Wojskowy Instytut Medyczny; 🇵🇱 Warszawa, Poland

Samodzielny Publiczny Centralny Szpital Kliniczny w Warszawie; 🇵🇱 Warszawa, Poland

Hospital Clinico Universitario de Santiago; 🇪🇸 La Coruña, Spain

Hospital De Cruces; 🇪🇸 Barakaldo, Spain

Hospital General Reina Sofia; 🇪🇸 Cordoba, Spain

Hospital Clinico San Carlos; 🇪🇸 Madrid, Spain

University Hospital of Wales; 🇬🇧 Cardiff, United Kingdom

Hospital Xeral Cies de Vigo; 🇪🇸 Pontevedra, Spain

Hospital Virgen Macarena; 🇪🇸 Sevilla, Spain

University Hospital; 🇬🇧 Coventry, United Kingdom

Hospital Universitario Miguel Servet; 🇪🇸 Zaragoza, Spain

Chrisite Hospital Institute; 🇬🇧 Manchester, United Kingdom

Freeman Hospital; 🇬🇧 Newcastle upon Tyne, United Kingdom

Royal Free Hospital; 🇬🇧 London, United Kingdom

University Hospital Aintree; 🇬🇧 Liverpool, United Kingdom