Angiosarcoma
Conditions
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.
Interventions
BIOLOGICALblood and urine
Blood collection and urine collection after consent of the patient
BEHAVIORALQuestionnaire
The patient complete the questionnaire alone at home
BEHAVIORALTelephone interview
The patient will be contacted by the CRA for a telephone interview of around one hour
Sponsors
Institut de Veille Sanitaire
Centre Oscar Lambret
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of identifying incident cases of angiosarcoma liver from the network NetSarc | At month 36 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Prospective surveillance in France | At month 36 | — |
| Description of occupational risk factors and environmental | At month 36 | 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 |
| Identification of biomarkers associated with human exposure Environmental old and new to vinyl chloride monomer | At 36 month | 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. |
| Assessment of the amount of vinyl chloride monomèredans successive addresses or nearby for cases without occupational exposure identified | At month 36 | 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 |
Countries
France
Outcome results
None listed