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

Sponsor

Ipsen (Industry)

Overall Status

Completed

CT.gov ID

NCT01234168

Collaborator

(none)

340

Enrollment

Locations

Duration (Months)

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Neuroendocrine Tumors Carcinoid Syndrome

Study Design

Study Type:

Observational

Actual Enrollment :

340 participants

Observational Model:

Cohort

Time Perspective:

Cross-Sectional

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

Study Start Date :

Oct 1, 2010

Actual Primary Completion Date :

Dec 1, 2012

Actual Study Completion Date :

Dec 1, 2012

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Teaching Hospital Brno Bohunice	Brno	Czechia
2	University Hospital Hradec Kralove	Hradec Kralove	Czechia
3	Hospital Pardubice	Pardubice	Czechia
4	Teaching Hospital	Plzen	Czechia
5	Charles University	Praha	Czechia
6	Teaching Hospital Na Bulovce	Praha	Czechia
7	CHU Angers	Angers	France	49933
8	Hôpital Avicenne	Bobigny	France	93009
9	Hôpital Saint André	Bordeaux	France	33075
10	CHU Trousseau	Chambray Les Tours	France	37171
11	Hôpital Beaujon	Clichy	France	92118
12	CHU Michallon	Grenoble	France	38043
13	Hôpital Edouard Herriot	Lyon	France	69437
14	CHU Timone	Marseille	France	13385
15	Hôpital Archet 2	Nice	France	06202
16	Hôpital du Haut Leveque	Pessac	France	33604
17	Hôpital Robert Debré	Reims	France	51092
18	CHU St Etienne	Saint Priest	France	42270
19	Hôpital Rangueil	Toulouse	France	31059
20	Institut Gustave-Roussy	Villejuif	France	94805
21	Semmelweis University	Budapest	Hungary	1088
22	Karádi-Nagy Bt.	Pécs	Hungary	7624
23	Hadasit Medical Research	Jerusalem	Israel
24	Ospedale Regina Apostolorum	Albano Laziale	Italy
25	Ospedale Pesenti Fenaroli	Alzano Lombardo	Italy
26	Ospedale Civile	Castelfranco Veneto	Italy
27	Università degli Studi di Chieti	Chieti	Italy
28	Istituti Ospedalieri di Cremona	Cremona	Italy
29	Azienda Ospedaliera-Universitaria Policlinico	Modena	Italy
30	U.O.C. Malattie dell'Apparato Digerente e del Fegato	Roma	Italy
31	Unità di Endocrinologia Istituti Fisioterapici Ospitalieri	Roma	Italy
32	Casa Sollievo della Sofferenza	San Giovanni Rotondo	Italy
33	Istituto Oncologico del Mediterraneo	Viagrande	Italy
34	Szpital Uniwersytecki im. A. Jurasza	Bydgoszcz	Poland
35	Slaskiego Uniwersytetu Medycznego	Katowice	Poland
36	Szpital Uniwersytecki w Krakowie	Krakow	Poland
37	Szpital Uniwersytecki w Lodzi	Lodz	Poland
38	Prywatna Praktyka Lekarska	Olsztyn	Poland
39	Specjalistyczny Gabinet Lekarski	Poznan	Poland
40	Samodzielny Publiczny Szpital Kliniczny Nr 1	Szczecin	Poland
41	Niepubliczny Zaklad Opieki Zdrowotnej	Warszawa	Poland
42	Samodzielny Publiczny Centralny Szpital Kliniczny w Warszawie	Warszawa	Poland
43	Wojskowy Instytut Medyczny	Warszawa	Poland
44	Hospital De Cruces	Barakaldo	Spain
45	Hospital Universitari de Bellvitge	Barcelona	Spain
46	Hospital General Reina Sofia	Cordoba	Spain
47	Hospital Clinico Universitario de Santiago	La Coruña	Spain
48	Hospital Clinico San Carlos	Madrid	Spain
49	Hospital Xeral Cies de Vigo	Pontevedra	Spain
50	Hospital Virgen Macarena	Sevilla	Spain
51	Hospital Universitario Miguel Servet	Zaragoza	Spain
52	University Hospital of Wales	Cardiff	United Kingdom	CF14 4XN
53	University Hospital	Coventry	United Kingdom	CV2 2DX
54	University Hospital Aintree	Liverpool	United Kingdom	L9 7AL
55	Royal Free Hospital	London	United Kingdom
56	Chrisite Hospital Institute	Manchester	United Kingdom	M204BX
57	Freeman Hospital	Newcastle upon Tyne	United Kingdom	NE7 7DN