Identification, Molecular Epidemiology Angiosarcoma of the Liver France

Not Applicable

• Conditions: Angiosarcoma
• Interventions: Biological: blood and urine; Behavioral: Questionnaire; Behavioral: Telephone interview

• Registration Number: NCT01786889
• Lead Sponsor: Centre Oscar Lambret

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.

Study Timeline

• Study First Submitted: 2013-02-06
• Study First Submitted QC: 2013-02-06
• Study First Posted: 2013-02-08
• Study Start: 2013-06
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-28
• Last Update Posted: 2016-07-29
• Primary Completion: 2016-09
• Study Completion: 2017-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 9

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patient with angiosarcoma of the liver	blood and urine	Blood and urine collections, questionnaire and telephone interview
Patient with angiosarcoma of the liver	Questionnaire	Blood and urine collections, questionnaire and telephone interview
Patient with angiosarcoma of the liver	Telephone interview	Blood and urine collections, questionnaire and telephone interview

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (12)

Hôpital de la TIMONE; 🇫🇷 Marseille, France

CRLCC Montpellier; 🇫🇷 Montpellier, France

Institut Claudius Regaud; 🇫🇷 Toulouse, France

Hopital Tenon; 🇫🇷 Paris, France

Institut de Cancérologie Lucien; 🇫🇷 St PRIEST EN JAREZ, France

Chu / Hopital Trousseau; 🇫🇷 Tours, France

CHU Strasbourg; 🇫🇷 Strasbourg, France

Institut Bergonié; 🇫🇷 Bordeaux, France

Centre Jean Perrin; 🇫🇷 Clermont-ferrand, France

Centre Georges François; 🇫🇷 Dijon, France

Centre Oscar Lambret; 🇫🇷 Lille, France

Centre Léon Bérard; 🇫🇷 Lyon, France