Identification, Molecular Epidemiology Angiosarcoma of the Liver France

NCT ID: NCT01786889

Last Updated: 2016-07-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2017-01-31

Brief Summary

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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

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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.

Conditions

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Angiosarcoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Patient with angiosarcoma of the liver

Blood and urine collections, questionnaire and telephone interview

Group Type EXPERIMENTAL

blood and urine

Intervention Type BIOLOGICAL

Blood collection and urine collection after consent of the patient

Questionnaire

Intervention Type BEHAVIORAL

The patient complete the questionnaire alone at home

Telephone interview

Intervention Type BEHAVIORAL

The patient will be contacted by the CRA for a telephone interview of around one hour

Interventions

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blood and urine

Blood collection and urine collection after consent of the patient

Intervention Type BIOLOGICAL

Questionnaire

The patient complete the questionnaire alone at home

Intervention Type BEHAVIORAL

Telephone interview

The patient will be contacted by the CRA for a telephone interview of around one hour

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institut de Veille Sanitaire

UNKNOWN

Sponsor Role collaborator

Centre Oscar Lambret

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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LE MOAL Joelle, Dr

Role: STUDY_DIRECTOR

Institut de Veille Sanitaire_Département Santé Environnement

PENEL Nicolas, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Oscar Lambret

Locations

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Institut Bergonié

Bordeaux, , France

Site Status

Centre Jean Perrin

Clermont-Ferrand, , France

Site Status

Centre Georges François

Dijon, , France

Site Status

Centre Oscar Lambret

Lille, , France

Site Status

Centre Léon Bérard

Lyon, , France

Site Status

Hôpital de la TIMONE

Marseille, , France

Site Status

CRLCC Montpellier

Montpellier, , France

Site Status

Hopital Tenon

Paris, , France

Site Status

Institut de Cancérologie Lucien

Saint-Priest-en-Jarez, , France

Site Status

CHU Strasbourg

Strasbourg, , France

Site Status

Institut Claudius Regaud

Toulouse, , France

Site Status

Chu / Hopital Trousseau

Tours, , France

Site Status

Countries

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France

Other Identifiers

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ANGI HE-1110

Identifier Type: -

Identifier Source: org_study_id

2012-A00739-34 (IDRCB Number)

Identifier Type: OTHER

Identifier Source: secondary_id

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