- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01786889
Identification, Molecular Epidemiology Angiosarcoma of the Liver France (ANGIHE)
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Bordeaux, France, 33076
- Institut Bergonie
-
Clermont-ferrand, France, 63000
- Centre Jean Perrin
-
Dijon, France, 21079
- Centre Georges François
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Lille, France, 59020
- Centre Oscar Lambret
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Lyon, France, 69373
- Centre Léon Berard
-
Marseille, France, 13385
- Hopital de La Timone
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Montpellier, France, 34298
- CRLCC Montpellier
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Paris, France, 75970
- Hopital Tenon
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St PRIEST EN JAREZ, France, 42 270
- Institut de Cancérologie Lucien
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Strasbourg, France, 67098
- CHU Strasbourg
-
Toulouse, France, 31052
- Institut Claudius Regaud
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Tours, France, 37000
- Chu / Hopital Trousseau
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
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)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Patient with angiosarcoma of the liver
Blood and urine collections, questionnaire and telephone interview
|
Blood collection and urine collection after consent of the patient
The patient complete the questionnaire alone at home
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
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
|
At month 36
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Prospective surveillance in France
Time Frame: At month 36
|
At month 36
|
|
Description of occupational risk factors and environmental
Time Frame: At month 36
|
Data will be collected using a questionnaire with:
|
At month 36
|
Identification of biomarkers associated with human exposure Environmental old and new to vinyl chloride monomer
Time Frame: At 36 month
|
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
Time Frame: At month 36
|
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
Collaborators
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
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
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)?
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