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

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

Study Overview

• Status: Unknown
• Conditions: Angiosarcoma
• Intervention / Treatment: Biological: blood and urine; Behavioral: Questionnaire; Behavioral: Telephone interview

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 Type: Interventional
• Enrollment (Actual): 9
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bordeaux, France, 33076
    • Institut Bergonié
  • Clermont-ferrand, France, 63000
    • Centre Jean Perrin
  • Dijon, France, 21079
    • Centre Georges François
  • Lille, France, 59020
    • Centre Oscar Lambret
  • Lyon, France, 69373
    • Centre léon bérard
  • Marseille, France, 13385
    • Hôpital de la Timone
  • Montpellier, France, 34298
    • CRLCC Montpellier
  • Paris, France, 75970
    • Hopital Tenon
  • St PRIEST EN JAREZ, France, 42 270
    • Institut de Cancérologie Lucien
  • Strasbourg, France, 67098
    • CHU Strasbourg
  • Toulouse, France, 31052
    • Institut Claudius Regaud
  • Tours, France, 37000
    • Chu / Hopital Trousseau

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Centre Oscar Lambret
• Collaborators: Institut de Veille Sanitaire
• Investigators: Principal Investigator: PENEL Nicolas, MD, Centre Oscar Lambret; Study Director: LE MOAL Joelle, Dr, Institut de Veille Sanitaire_Département Santé Environnement

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Anticipated): September 1, 2016
• Study Completion (Anticipated): January 1, 2017

Study Registration Dates

• First Submitted: February 6, 2013
• First Submitted That Met QC Criteria: February 6, 2013
• First Posted (Estimate): February 8, 2013

Study Record Updates

• Last Update Posted (Estimate): July 29, 2016
• Last Update Submitted That Met QC Criteria: July 28, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma; Neoplasms, Vascular Tissue; Hemangiosarcoma
• Other Study ID Numbers: ANGI HE-1110; 2012-A00739-34 (IDRCB Number) (Other Identifier: AFSSAPS)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No