Clinical trial NCT01786889: Identification, Molecular Epidemiology Angiosarcoma of the Liver France
Official title: Identification, Molecular Epidemiology Angiosarcoma of the Liver France
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Angiosarcoma
Lead sponsor: Centre Oscar Lambret
Sponsor class: OTHER
Collaborators: name: Institut de Veille Sanitaire
First posted: 2013-02-08
Enrollment: 9
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to test the feasibility of identifying incident cases of angiosarcoma of the liver from the network NetSarc.

Detailed description: The study involves a questionnaire and a one-hour telephone interview.

Consultation:

* Study proposal
* Information and collection of the patient's and/or parent's written consents
* Blood collection (10ml) and urine collection of the patient and parents if applicable
* Delivery of a specific questionnaire and a stamped envelope (with the address of the coordinator's center). If it's about a child patient or an adolescent under 18 years, 3 questionnaires will be given (1 for each parent and 1 for the child).

At home: Filling the questionnaire by the patient and/or the parents, alone at home and return to the coordinator via the given envelope.

During the study: Collect of the initial biopsies used for the hepatic angiosarcoma's diagnostic.

End of the study: Telephone interview CRA/Patient and/or parents to complete the questionnaires (around one hour). From this data will be reconstitute the residential process of the patient and parents if it's about a child or an adolescent (collection of the successive addresses).

Finally, water collections, according to a defined sampling protocol, at the tap of the different homes and places visited by the patients will be organized by the InvS in relation to the ARS within the scope of water quality controls, in order to evaluate the exposition to vinyl chloride monomer (VCM) by hydric ways.

Eligibility criteria: Inclusion Criteria:

* Any patient with angiosarcoma of the liver (angiosarcoma immediately multifocal allowed) diagnosed by histology from the start of the study
* The patient's written Consent

No exclusion criteria

Primary outcomes:
measure: Feasibility of identifying incident cases of angiosarcoma liver from the network NetSarc
timeFrame: At month 36
Secondary outcomes:
measure: Prospective surveillance in France
timeFrame: At month 36
measure: Description of occupational risk factors and environmental
timeFrame: At month 36
measure: Identification of biomarkers associated with human exposure Environmental old and new to vinyl chloride monomer
timeFrame: At 36 month
measure: Assessment of the amount of vinyl chloride monomèredans successive addresses or nearby for cases without occupational exposure identified
timeFrame: At month 36
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Institut Bergonié
city: Clermont-ferrand
country: France
facility: Centre Jean Perrin
city: Dijon
country: France
facility: Centre Georges François
city: Lille
country: France
facility: Centre Oscar Lambret
city: Lyon
country: France
facility: Centre Léon Bérard
city: Marseille
country: France
facility: Hôpital de la TIMONE
city: Montpellier
country: France
facility: CRLCC Montpellier
city: Paris
country: France
facility: Hopital Tenon
city: St PRIEST EN JAREZ
country: France
facility: Institut de Cancérologie Lucien
city: Strasbourg
country: France
facility: CHU Strasbourg
city: Toulouse
country: France
facility: Institut Claudius Regaud
city: Tours
country: France
facility: Chu / Hopital Trousseau
Study officials:
affiliation: Institut de Veille Sanitaire_Département Santé Environnement
name: LE MOAL Joelle, Dr
role: STUDY_DIRECTOR
affiliation: Centre Oscar Lambret
name: PENEL Nicolas, MD
role: PRINCIPAL_INVESTIGATOR
References: