Neuroendocrine TumorsSYMNETNCT01234168
A Study to Assess Neuroendocrine Tumour (NET) Patients Currently Treated by Somatuline Autogel for History of Carcinoid Syndrome Associated With Episodes of Diarrhea
An observational study of Neuroendocrine Tumors and Carcinoid Syndrome, run by Ipsen at 57 sites in 8 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuroendocrine Tumors, Carcinoid Syndrome
- How many people
- 340 participants
- Where
- 57 sitesin 8 countries
- Study dates
- Oct 2010to Dec 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Out-patients
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
57 sites in 8 countries.
57 sites in 8 countries
France14 sites
CHU Angers
Angers, 49933
Hôpital Avicenne
Bobigny, 93009
Hôpital Saint André
Bordeaux, 33075
CHU Trousseau
Chambray-lès-Tours, 37171
Hôpital Beaujon
Clichy, 92118
CHU Michallon
Grenoble, 38043
Hôpital Edouard Herriot
Lyon, 69437
CHU Timone
Marseille, 13385
Hôpital Archet 2
Nice, 06202
Hôpital du Haut Leveque
Pessac, 33604
Hôpital Robert Debré
Reims, 51092
CHU St Etienne
Saint-Priest, 42270
Hôpital Rangueil
Toulouse, 31059
Institut Gustave-Roussy
Villejuif, 94805
Italy10 sites
Ospedale Regina Apostolorum
Albano Laziale
Ospedale Pesenti Fenaroli
Alzano Lombardo
Ospedale Civile
Castelfranco Veneto
Università degli Studi di Chieti
Chieti
Istituti Ospedalieri di Cremona
Cremona
Azienda Ospedaliera-Universitaria Policlinico
Modena
U.O.C. Malattie dell'Apparato Digerente e del Fegato
Roma
Unità di Endocrinologia Istituti Fisioterapici Ospitalieri
Roma
Casa Sollievo della Sofferenza
San Giovanni Rotondo
Istituto Oncologico del Mediterraneo
Viagrande
Poland10 sites
Szpital Uniwersytecki im. A. Jurasza
Bydgoszcz
Slaskiego Uniwersytetu Medycznego
Katowice
Szpital Uniwersytecki w Krakowie
Krakow
Szpital Uniwersytecki w Lodzi
Lodz
Prywatna Praktyka Lekarska
Olsztyn
Specjalistyczny Gabinet Lekarski
Poznan
Samodzielny Publiczny Szpital Kliniczny Nr 1
Szczecin
Niepubliczny Zaklad Opieki Zdrowotnej
Warsaw
Samodzielny Publiczny Centralny Szpital Kliniczny w Warszawie
Warsaw
Wojskowy Instytut Medyczny
Warsaw
Spain8 sites
Hospital Clinico Universitario de Santiago
A Coruña
Hospital De Cruces
Barakaldo
Hospital Universitari de Bellvitge
Barcelona
Hospital General Reina Sofia
Córdoba
Hospital Clinico San Carlos
Madrid
Hospital Xeral Cies de Vigo
Pontevedra
Hospital Virgen Macarena
Seville
Hospital Universitario Miguel Servet
Zaragoza
Czechia6 sites
Teaching Hospital Brno Bohunice
Brno
University Hospital Hradec Kralove
Hradec Králové
Hospital Pardubice
Pardubice
Teaching Hospital
Pilsen
Charles University
Prague
Teaching Hospital Na Bulovce
Prague
United Kingdom6 sites
University Hospital of Wales
Cardiff, CF14 4XN
University Hospital
Coventry, CV2 2DX
University Hospital Aintree
Liverpool, L9 7AL
Royal Free Hospital
London
Chrisite Hospital Institute
Manchester, M204BX
Freeman Hospital
Newcastle upon Tyne, NE7 7DN
About this study
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
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.
- Conditions
- Neuroendocrine Tumors, Carcinoid Syndrome
- Medical subject headings
- Neuroendocrine Tumors, Serotonin Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Subject's overall satisfaction regarding control of diarrhea
Use of questionnaires to assess patient satisfaction (Likert scale).
Measured: Day of survey
Secondary outcomes (1)
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).
Measured: Day of survey
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2010 (estimated)
- Study startOct 2010
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neuroendocrine TumorsStudies of the same condition, open and under way.
- More trials run by IpsenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 340 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ipsen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ipsen Study Director, Study director, Ipsen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01234168
- Sponsor's protocol ID
- 8-79-52030-736
- Acronym
- SYMNET
- Status last verified
- Nov 2020
- First submitted
- 20 Oct 2010
- Last updated
- 5 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26917486
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01234168
- Acronym / sponsor ID
- SYMNET / 8-79-52030-736
- Conditions
- Neuroendocrine Tumors, Carcinoid Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 340 participants (actual)
- Lead sponsor
- IpsenIndustry (pharma, biotech, devices)
- Study start
- Oct 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 4 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Out-patients
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Subject's overall satisfaction regarding control of diarrhea
Time frame: Day of survey
Use of questionnaires to assess patient satisfaction (Likert scale).
1 secondary outcome
Impact on daily activities of the clinical manifestations of diarrhea
Time frame: Day of survey
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2020.
- Derived from this study: PubMed 26917486Ruszniewski 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ipsen Study Director study director
Ipsen
57 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuroendocrine Tumors and Carcinoid Syndrome, run by Ipsen at 57 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 57 sites in France, Italy, Poland, Spain, Czechia and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subject's overall satisfaction regarding control of diarrhea (time frame: Day of survey). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01234168, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2020.