Identification, Molecular Epidemiology Angiosarcoma of the Liver France

Angiosarcoma Clinical Trial

— ANGIHE  

Official title:

Identification, Molecular Epidemiology Angiosarcoma of the Liver France

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01786889
• Other study ID #: ANGI HE-1110
• Secondary ID: 2012-A00739-34 (
• Status: Active, not recruiting
• Phase: N/A
• First received: February 6, 2013
• Last updated: July 28, 2016
• Start date: June 2013
• Est. completion date: January 2017

Study information

• Verified date: July 2016
• Source: Centre Oscar Lambret
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santéFrance: Committee for the Protection of PersonnesFrance: The Commission nationale de l’informatique et des libertésFrance: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 9
• Est. completion date: January 2017
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Angiosarcoma

Intervention

Biological:
• blood and urine
Blood collection and urine collection after consent of the patient

Behavioral:
• Questionnaire
The patient complete the questionnaire alone at home
• Telephone interview
The patient will be contacted by the CRA for a telephone interview of around one hour

Locations

Country	Name	City	State
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	Hôpital de la TIMONE	Marseille
France	CRLCC Montpellier	Montpellier
France	Hopital Tenon	Paris
France	Institut de Cancérologie Lucien	St PRIEST EN JAREZ
France	CHU Strasbourg	Strasbourg
France	Institut Claudius Regaud	Toulouse
France	Chu / Hopital Trousseau	Tours

Sponsors (2)

Lead Sponsor	Collaborator
Centre Oscar Lambret	Institut de Veille Sanitaire

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Prospective surveillance in France		At month 36	No
Secondary	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	No
Secondary	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	No
Secondary	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	No