Identification, Molecular Epidemiology Angiosarcoma of the Liver France

Study Overview
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Brief Summary
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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
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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.

Official Title
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Identification, Molecular Epidemiology Angiosarcoma of the Liver France

Conditions
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Angiosarcoma

Intervention / Treatment
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* Biological: blood and urine
* Behavioral: Questionnaire
* Behavioral: Telephone interview


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patient with angiosarcoma of the liver<br>Blood and urine collections, questionnaire and telephone interview | Biological: blood and urine<br>* Blood collection and urine collection after consent of the patient<br>Behavioral: Questionnaire<br>* The patient complete the questionnaire alone at home<br>Behavioral: Telephone interview<br>* The patient will be contacted by the CRA for a telephone interview of around one hour<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of identifying incident cases of angiosarcoma liver from the network NetSarc | Feasibility of identifying incident cases of angiosarcoma of the liver (ASF) from the network NetSarc: number of sheets indicated and returned to the Promoter. 30 cases are expected, the cumulative number of incident cases will be measured over a period of 36 months | At month 36 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prospective surveillance in France |  | At month 36 | 
| Description of occupational risk factors and environmental | Data will be collected using a questionnaire with: Exhaustive search of all occupational and environmental exposures as known or suspected risk factors for ASF Reconstruction of residential history and haunts each case by means of a collection of successive addresses | At month 36 | 
| Identification of biomarkers associated with human exposure Environmental old and new to vinyl chloride monomer | Research suggestive of carcinogenesis related to CVM (identified in animal models and cohorts of workers exposed) biomarkers will be made by biological testing (blood and urine) adducts éthénobases kind resulting from the reaction of metabolites with CVM DNA and specific gene mutations k-ras and p53. Exposure to arsenic via the determination of Arsenic urinaire.sera sought. The p53 and K-ras genes are also sequences from initial diagnostic biopsies. | At 36 month | 
| Assessment of the amount of vinyl chloride monomèredans successive addresses or nearby for cases without occupational exposure identified | Data will be collected using a questionnaire with: - Assessment of the amount of vinyl chloride monomer (VCM) in successive addresses or nearby for cases without occupational exposure identified | At month 36 |