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

November 4, 2020 updated by: Ipsen

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

340

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
      • Brno, Czechia
        • Teaching Hospital Brno Bohunice
      • Hradec Kralove, Czechia
        • University Hospital Hradec Kralove
      • Pardubice, Czechia
        • Hospital Pardubice
      • Plzen, Czechia
        • Teaching Hospital
      • Praha, Czechia
        • Charles University
      • Praha, Czechia
        • Teaching Hospital Na Bulovce
  • France
      • Angers, France, 49933
        • CHU Angers
      • Bobigny, France, 93009
        • Hopital Avicenne
      • Bordeaux, France, 33075
        • Hôpital Saint André
      • Chambray Les Tours, France, 37171
        • CHU Trousseau
      • Clichy, France, 92118
        • Hopital Beaujon
      • Grenoble, France, 38043
        • CHU Michallon
      • Lyon, France, 69437
        • Hôpital Edouard Herriot
      • Marseille, France, 13385
        • CHU Timone
      • Nice, France, 06202
        • Hôpital Archet 2
      • Pessac, France, 33604
        • Hôpital du Haut Lévêque
      • Reims, France, 51092
        • Hopital Robert Debre
      • Saint Priest, France, 42270
        • CHU St Etienne
      • Toulouse, France, 31059
        • Hôpital Rangueil
      • Villejuif, France, 94805
        • Institut Gustave-Roussy
  • Hungary
      • Budapest, Hungary, 1088
        • Semmelweis University
      • Pécs, Hungary, 7624
        • Karádi-Nagy Bt.
  • Israel
      • Jerusalem, Israel
        • Hadasit Medical Research
  • Italy
      • Albano Laziale, Italy
        • Ospedale Regina Apostolorum
      • Alzano Lombardo, Italy
        • Ospedale Pesenti Fenaroli
      • Castelfranco Veneto, Italy
        • Ospedale Civile
      • Chieti, Italy
        • Università degli Studi di Chieti
      • Cremona, Italy
        • Istituti Ospedalieri di Cremona
      • Modena, Italy
        • Azienda Ospedaliera-Universitaria Policlinico
      • Roma, Italy
        • U.O.C. Malattie dell'Apparato Digerente e del Fegato
      • Roma, Italy
        • Unità di Endocrinologia Istituti Fisioterapici Ospitalieri
      • San Giovanni Rotondo, Italy
        • Casa Sollievo della Sofferenza
      • Viagrande, Italy
        • Istituto Oncologico del Mediterraneo
  • Poland
      • Bydgoszcz, Poland
        • Szpital Uniwersytecki im. A. Jurasza
      • Katowice, Poland
        • Slaskiego Uniwersytetu Medycznego
      • Krakow, Poland
        • Szpital Uniwersytecki w Krakowie
      • Lodz, Poland
        • Szpital Uniwersytecki w Lodzi
      • Olsztyn, Poland
        • Prywatna Praktyka Lekarska
      • Poznan, Poland
        • Specjalistyczny Gabinet Lekarski
      • Szczecin, Poland
        • Samodzielny Publiczny Szpital Kliniczny Nr 1
      • Warszawa, Poland
        • Wojskowy Instytut Medyczny
      • Warszawa, Poland
        • Niepubliczny Zaklad Opieki Zdrowotnej
      • Warszawa, Poland
        • Samodzielny Publiczny Centralny Szpital Kliniczny w Warszawie
  • Spain
      • Barakaldo, Spain
        • Hospital de Cruces
      • Barcelona, Spain
        • Hospital Universitari de Bellvitge
      • Cordoba, Spain
        • Hospital General Reina Sofía
      • La Coruña, Spain
        • Hospital Clinico Universitario de Santiago
      • Madrid, Spain
        • Hospital Clinico San Carlos
      • Pontevedra, Spain
        • Hospital Xeral Cies de Vigo
      • Sevilla, Spain
        • Hospital Virgen Macarena
      • Zaragoza, Spain
        • Hospital Universitario Miguel Servet
  • United Kingdom
      • Cardiff, United Kingdom, CF14 4XN
        • University Hospital of Wales
      • Coventry, United Kingdom, CV2 2DX
        • University Hospital
      • Liverpool, United Kingdom, L9 7AL
        • University Hospital Aintree
      • London, United Kingdom
        • Royal Free Hospital
      • Manchester, United Kingdom, M204BX
        • Chrisite Hospital Institute
      • Newcastle upon Tyne, United Kingdom, NE7 7DN
        • Freeman Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Out-patients

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subject's overall satisfaction regarding control of diarrhea
Time Frame: Day of survey
Use of questionnaires to assess patient satisfaction (Likert scale).
Day of survey

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ipsen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

October 20, 2010

First Submitted That Met QC Criteria

November 3, 2010

First Posted (Estimate)

November 4, 2010

Study Record Updates

Last Update Posted (Actual)

November 5, 2020

Last Update Submitted That Met QC Criteria

November 4, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8-79-52030-736

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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