Identification, Molecular Epidemiology Angiosarcoma of the Liver France (ANGIHE)
Primary Purpose
Angiosarcoma
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
blood and urine
Questionnaire
Telephone interview
Sponsored by
About this trial
This is an interventional prevention trial for Angiosarcoma
Eligibility 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
Sites / Locations
- Institut Bergonié
- Centre Jean Perrin
- Centre Georges François
- Centre Oscar Lambret
- Centre Léon Bérard
- Hôpital de la TIMONE
- CRLCC Montpellier
- Hopital Tenon
- Institut de Cancérologie Lucien
- CHU Strasbourg
- Institut Claudius Regaud
- Chu / Hopital Trousseau
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patient with angiosarcoma of the liver
Arm Description
Blood and urine collections, questionnaire and telephone interview
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Prospective surveillance in France
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
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.
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
Full Information
NCT ID
NCT01786889
First Posted
February 6, 2013
Last Updated
July 28, 2016
Sponsor
Centre Oscar Lambret
Collaborators
Institut de Veille Sanitaire
1. Study Identification
Unique Protocol Identification Number
NCT01786889
Brief Title
Identification, Molecular Epidemiology Angiosarcoma of the Liver France
Acronym
ANGIHE
Official Title
Identification, Molecular Epidemiology Angiosarcoma of the Liver France
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Unknown status
Study Start Date
June 2013 (undefined)
Primary Completion Date
September 2016 (Anticipated)
Study Completion Date
January 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Oscar Lambret
Collaborators
Institut de Veille Sanitaire
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Angiosarcoma
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patient with angiosarcoma of the liver
Arm Type
Experimental
Arm Description
Blood and urine collections, questionnaire and telephone interview
Intervention Type
Biological
Intervention Name(s)
blood and urine
Intervention Description
Blood collection and urine collection after consent of the patient
Intervention Type
Behavioral
Intervention Name(s)
Questionnaire
Intervention Description
The patient complete the questionnaire alone at home
Intervention Type
Behavioral
Intervention Name(s)
Telephone interview
Intervention Description
The patient will be contacted by the CRA for a telephone interview of around one hour
Primary Outcome Measure Information:
Title
Feasibility of identifying incident cases of angiosarcoma liver from the network NetSarc
Description
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
Time Frame
At month 36
Secondary Outcome Measure Information:
Title
Prospective surveillance in France
Time Frame
At month 36
Title
Description of occupational risk factors and environmental
Description
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
Time Frame
At month 36
Title
Identification of biomarkers associated with human exposure Environmental old and new to vinyl chloride monomer
Description
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.
Time Frame
At 36 month
Title
Assessment of the amount of vinyl chloride monomèredans successive addresses or nearby for cases without occupational exposure identified
Description
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
Time Frame
At month 36
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
LE MOAL Joelle, Dr
Organizational Affiliation
Institut de Veille Sanitaire_Département Santé Environnement
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
PENEL Nicolas, MD
Organizational Affiliation
Centre Oscar Lambret
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut Bergonié
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
Centre Jean Perrin
City
Clermont-ferrand
ZIP/Postal Code
63000
Country
France
Facility Name
Centre Georges François
City
Dijon
ZIP/Postal Code
21079
Country
France
Facility Name
Centre Oscar Lambret
City
Lille
ZIP/Postal Code
59020
Country
France
Facility Name
Centre Léon Bérard
City
Lyon
ZIP/Postal Code
69373
Country
France
Facility Name
Hôpital de la TIMONE
City
Marseille
ZIP/Postal Code
13385
Country
France
Facility Name
CRLCC Montpellier
City
Montpellier
ZIP/Postal Code
34298
Country
France
Facility Name
Hopital Tenon
City
Paris
ZIP/Postal Code
75970
Country
France
Facility Name
Institut de Cancérologie Lucien
City
St PRIEST EN JAREZ
ZIP/Postal Code
42 270
Country
France
Facility Name
CHU Strasbourg
City
Strasbourg
ZIP/Postal Code
67098
Country
France
Facility Name
Institut Claudius Regaud
City
Toulouse
ZIP/Postal Code
31052
Country
France
Facility Name
Chu / Hopital Trousseau
City
Tours
ZIP/Postal Code
37000
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Identification, Molecular Epidemiology Angiosarcoma of the Liver France
We'll reach out to this number within 24 hrs