Identification, Molecular Epidemiology Angiosarcoma of the Liver France (ANGIHE)

Centre Oscar Lambret

Status: Unknown

Conditions: Angiosarcoma

Treatments: Behavioral: Questionnaire; Behavioral: Telephone interview; Biological: blood and urine

Study type: Interventional

Funder types: Other

Identifiers

NCT01786889

2012-A00739-34 (IDRCB Number) (Other Identifier)

ANGI HE-1110

Details and patient eligibility

About

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

Full 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.

Enrollment: 9 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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9 participants in 1 patient group

Patient with angiosarcoma of the liver

Experimental group

Description:

Blood and urine collections, questionnaire and telephone interview

Treatment:

Behavioral: Telephone interview

Behavioral: Questionnaire

Biological: blood and urine