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

Neuroendocrine Tumors Clinical Trial

— SYMNET  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01234168
• Other study ID #: 8-79-52030-736
• Status: Completed
• Start date: October 2010
• Est. completion date: December 2012

Study information

• Verified date: November 2020
• Source: Ipsen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• 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).

Related Conditions & MeSH terms

• Carcinoid Syndrome
• Carcinoid Tumor
• Diarrhea
• Malignant Carcinoid Syndrome
• Neuroendocrine Tumors
• Serotonin Syndrome
• Syndrome

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Ipsen

Countries where clinical trial is conducted

Czechia,  France,  Hungary,  Israel,  Italy,  Poland,  Spain,  United Kingdom, 

Outcome

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