Identification, Molecular Epidemiology Angiosarcoma of the Liver France
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Centre Oscar Lambret
- Enrollment
- 9
- Locations
- 12
- Primary Endpoint
- Feasibility of identifying incident cases of angiosarcoma liver from the network NetSarc
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts 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
Exclusion Criteria
- Not provided
Arms & Interventions
Patient with angiosarcoma of the liver
Blood and urine collections, questionnaire and telephone interview
Intervention: blood and urine (Biological)
Patient with angiosarcoma of the liver
Blood and urine collections, questionnaire and telephone interview
Intervention: Questionnaire (Behavioral)
Patient with angiosarcoma of the liver
Blood and urine collections, questionnaire and telephone interview
Intervention: Telephone interview (Behavioral)
Outcomes
Primary Outcomes
Feasibility of identifying incident cases of angiosarcoma liver from the network NetSarc
Time Frame: 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 Outcomes
- Prospective surveillance in France(At month 36)
- Description of occupational risk factors and environmental(At month 36)
- Identification of biomarkers associated with human exposure Environmental old and new to vinyl chloride monomer(At 36 month)
- Assessment of the amount of vinyl chloride monomèredans successive addresses or nearby for cases without occupational exposure identified(At month 36)