Clinical trial NCT01234168: A Study to Assess Neuroendocrine Tumour (NET) Patients Currently Treated by Somatuline Autogel for History of Carcinoid Syndrome Associated With Episodes of Diarrhea
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neuroendocrine Tumors
Carcinoid Syndrome
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2010-11-04
Enrollment: 340
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Out-patients

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Subject's overall satisfaction regarding control of diarrhea
timeFrame: Day of survey
Secondary outcomes:
measure: Impact on daily activities of the clinical manifestations of diarrhea
timeFrame: Day of survey
Other outcomes:
Locations:
city: Brno
country: Czechia
facility: Teaching Hospital Brno Bohunice
city: Hradec Kralove
country: Czechia
facility: University Hospital Hradec Kralove
city: Pardubice
country: Czechia
facility: Hospital Pardubice
city: Plzen
country: Czechia
facility: Teaching Hospital
city: Praha
country: Czechia
facility: Charles University
city: Praha
country: Czechia
facility: Teaching Hospital Na Bulovce
city: Angers
country: France
facility: CHU Angers
city: Bobigny
country: France
facility: Hôpital Avicenne
city: Bordeaux
country: France
facility: Hôpital Saint André
city: Chambray Les Tours
country: France
facility: CHU Trousseau
city: Clichy
country: France
facility: Hôpital Beaujon
city: Grenoble
country: France
facility: CHU Michallon
city: Lyon
country: France
facility: Hôpital Edouard Herriot
city: Marseille
country: France
facility: CHU Timone
city: Nice
country: France
facility: Hôpital Archet 2
city: Pessac
country: France
facility: Hôpital du Haut Leveque
city: Reims
country: France
facility: Hôpital Robert Debré
city: Saint Priest
country: France
facility: CHU St Etienne
city: Toulouse
country: France
facility: Hôpital Rangueil
city: Villejuif
country: France
facility: Institut Gustave-Roussy
city: Budapest
country: Hungary
facility: Semmelweis University
city: Pécs
country: Hungary
facility: Karádi-Nagy Bt.
city: Jerusalem
country: Israel
facility: Hadasit Medical Research
city: Albano Laziale
country: Italy
facility: Ospedale Regina Apostolorum
city: Alzano Lombardo
country: Italy
facility: Ospedale Pesenti Fenaroli
city: Castelfranco Veneto
country: Italy
facility: Ospedale Civile
city: Chieti
country: Italy
facility: Università degli Studi di Chieti
city: Cremona
country: Italy
facility: Istituti Ospedalieri di Cremona
city: Modena
country: Italy
facility: Azienda Ospedaliera-Universitaria Policlinico
city: Roma
country: Italy
facility: U.O.C. Malattie dell'Apparato Digerente e del Fegato
city: Roma
country: Italy
facility: Unità di Endocrinologia Istituti Fisioterapici Ospitalieri
city: San Giovanni Rotondo
country: Italy
facility: Casa Sollievo della Sofferenza
city: Viagrande
country: Italy
facility: Istituto Oncologico del Mediterraneo
city: Bydgoszcz
country: Poland
facility: Szpital Uniwersytecki im. A. Jurasza
city: Katowice
country: Poland
facility: Slaskiego Uniwersytetu Medycznego
city: Krakow
country: Poland
facility: Szpital Uniwersytecki w Krakowie
city: Lodz
country: Poland
facility: Szpital Uniwersytecki w Lodzi
city: Olsztyn
country: Poland
facility: Prywatna Praktyka Lekarska
city: Poznan
country: Poland
facility: Specjalistyczny Gabinet Lekarski
city: Szczecin
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny Nr 1
city: Warszawa
country: Poland
facility: Niepubliczny Zaklad Opieki Zdrowotnej
city: Warszawa
country: Poland
facility: Samodzielny Publiczny Centralny Szpital Kliniczny w Warszawie
city: Warszawa
country: Poland
facility: Wojskowy Instytut Medyczny
city: Barakaldo
country: Spain
facility: Hospital De Cruces
city: Barcelona
country: Spain
facility: Hospital Universitari de Bellvitge
city: Cordoba
country: Spain
facility: Hospital General Reina Sofia
city: La Coruña
country: Spain
facility: Hospital Clinico Universitario de Santiago
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Pontevedra
country: Spain
facility: Hospital Xeral Cies de Vigo
city: Sevilla
country: Spain
facility: Hospital Virgen Macarena
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet
city: Cardiff
country: United Kingdom
facility: University Hospital of Wales
city: Coventry
country: United Kingdom
facility: University Hospital
city: Liverpool
country: United Kingdom
facility: University Hospital Aintree
city: London
country: United Kingdom
facility: Royal Free Hospital
city: Manchester
country: United Kingdom
facility: Chrisite Hospital Institute
city: Newcastle upon Tyne
country: United Kingdom
facility: Freeman Hospital
Study officials:
affiliation: Ipsen
name: Ipsen Study Director
role: STUDY_DIRECTOR
References:
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.