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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-A00739-34 (IDRCB Number) | Other Identifier | AFSSAPS |
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| Name | Class |
|---|---|
| Institut de Veille Sanitaire | UNKNOWN |
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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.
The study involves a questionnaire and a one-hour telephone interview.
Consultation:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient with angiosarcoma of the liver | Experimental | Blood and urine collections, questionnaire and telephone interview |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| blood and urine | Biological | Blood collection and urine collection after consent of the patient |
|
| 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 |
| 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:
|
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Inclusion Criteria:
No exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| LE MOAL Joelle, Dr | Institut de Veille Sanitaire_Département Santé Environnement | Study Director |
| PENEL Nicolas, MD | Centre Oscar Lambret | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Bergonié | Bordeaux | 33076 | France | |||
| Centre Jean Perrin |
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| ID | Term |
|---|---|
| D006394 | Hemangiosarcoma |
| ID | Term |
|---|---|
| D012509 | Sarcoma |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| D014554 | Urination |
| D011795 | Surveys and Questionnaires |
| D007407 | Interviews as Topic |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| Questionnaire | Behavioral | The patient complete the questionnaire alone at home |
|
| Telephone interview | Behavioral | The patient will be contacted by the CRA for a telephone interview of around one hour |
|
| 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 |
| Clermont-Ferrand |
| 63000 |
| France |
| Centre Georges François | Dijon | 21079 | France |
| Centre Oscar Lambret | Lille | 59020 | France |
| Centre Léon Bérard | Lyon | 69373 | France |
| Hôpital de la TIMONE | Marseille | 13385 | France |
| CRLCC Montpellier | Montpellier | 34298 | France |
| Hopital Tenon | Paris | 75970 | France |
| Institut de Cancérologie Lucien | Saint-Priest-en-Jarez | 42 270 | France |
| CHU Strasbourg | Strasbourg | 67098 | France |
| Institut Claudius Regaud | Toulouse | 31052 | France |
| Chu / Hopital Trousseau | Tours | 37000 | France |
| D009383 |
| Neoplasms, Vascular Tissue |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| D014553 | Urinary Tract Physiological Phenomena |
| D012101 | Reproductive and Urinary Physiological Phenomena |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |