NCT01786889

Identification, Molecular Epidemiology Angiosarcoma of the Liver France

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Centre Oscar Lambret · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Angiosarcoma

Interventions

Type	Name	Description
BIOLOGICAL	blood and urine	Blood collection and urine collection after consent of the patient
BEHAVIORAL	Questionnaire	The patient complete the questionnaire alone at home
BEHAVIORAL	Telephone interview	The patient will be contacted by the CRA for a telephone interview of around one hour

Timeline

• Start date: 2013-06-01
• Primary completion: 2016-09-01
• Completion: 2017-01-01
• First posted: 2013-02-08
• Last updated: 2016-07-29

Locations

12 sites across 1 country: France