AngiosarcomaANGIHENCT01786889
Identification, Molecular Epidemiology Angiosarcoma of the Liver France
A study testing blood and urine, Questionnaire and Telephone interview in people with Angiosarcoma, run by Centre Oscar Lambret at 12 sites in France.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Angiosarcoma
- What is being tested?
- blood and urine, Questionnaire and Telephone interview
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 12 sitesFrance
- Study dates
- Jun 2013to Jan 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
France12 sites
Institut Bergonié
Bordeaux, 33076
Centre Jean Perrin
Clermont-Ferrand, 63000
Centre Georges François
Dijon, 21079
Centre Oscar Lambret
Lille, 59020
Centre Léon Bérard
Lyon, 69373
Hôpital de la TIMONE
Marseille, 13385
CRLCC Montpellier
Montpellier, 34298
Hopital Tenon
Paris, 75970
Institut de Cancérologie Lucien
Saint-Priest-en-Jarez, 42 270
CHU Strasbourg
Strasbourg, 67098
Institut Claudius Regaud
Toulouse, 31052
Chu / Hopital Trousseau
Tours, 37000
About this study
The purpose of this study is to test the feasibility of identifying incident cases of angiosarcoma of the liver from the network NetSarc.
Read the 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.
- Conditions
- Angiosarcoma
- Being tested
- blood and urine, Questionnaire, Telephone interview
- Medical subject headings
- Hemangiosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood and urineBiological
Blood collection and urine collection after consent of the patient
QuestionnaireBehavioural
The patient complete the questionnaire alone at home
Telephone interviewBehavioural
The patient will be contacted by the CRA for a telephone interview of around one hour
| Study group | Role | What they receive |
|---|---|---|
| Patient with angiosarcoma of the liver | Experimental | Blood and urine collections, questionnaire and telephone interview Receives: Biological: blood and urine; Behavioral: Questionnaire; Behavioral: Telephone interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At month 36
Secondary outcomes (4)
Prospective surveillance in France
Measured: At month 36
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
Measured: 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.
Measured: 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
Measured: At month 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2013 (estimated)
- Study startJun 2013
- Primary completionSep 2016 (estimated)
- Study completionJan 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AngiosarcomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Oscar Lambret
- Sponsor type
- University, hospital or other
- Collaborators
- Institut de Veille Sanitaire
- Responsible party
- Sponsor
- Investigators
- LE MOAL Joelle, Dr, Study director, Institut de Veille Sanitaire_Département Santé EnvironnementPENEL Nicolas, MD, Principal investigator, Centre Oscar Lambret
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01786889
- Sponsor's protocol ID
- ANGI HE-1110
- Other IDs
- 2012-A00739-34 (IDRCB Number)
- Acronym
- ANGIHE
- Status last verified
- Jul 2016
- First submitted
- 6 Feb 2013
- Last updated
- 29 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification, Molecular Epidemiology Angiosarcoma of the Liver France
- ClinicalTrials.gov ID
- NCT01786889
- Acronym / sponsor ID
- ANGIHE / ANGI HE-1110
- Conditions
- Angiosarcoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Centre Oscar LambretUniversity, hospital or other
- Collaborators
- Institut de Veille Sanitaire
- Study start
- Jun 2013
- Primary completion
- Sep 2016 (estimated)
- Study completion
- Jan 2017 (estimated)
- First posted
- 8 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient with angiosarcoma of the liver | Experimental | Biological: blood and urine, Behavioral: Questionnaire, Behavioral: Telephone interviewBlood and urine collections, questionnaire and telephone interview |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood and urineBlood collection and urine collection after consent of the patient | Biological | Patient with angiosarcoma of the liver |
| QuestionnaireThe patient complete the questionnaire alone at home | Behavioural | Patient with angiosarcoma of the liver |
| Telephone interviewThe patient will be contacted by the CRA for a telephone interview of around one hour | Behavioural | Patient with angiosarcoma of the liver |
Primary outcome
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
4 secondary outcomes
Prospective surveillance in France
Time frame: At month 36
Description of occupational risk factors and environmental
Time frame: At month 36
Identification of biomarkers associated with human exposure Environmental old and new to vinyl chloride monomer
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
LE MOAL Joelle, Dr study director
Institut de Veille Sanitaire_Département Santé Environnement
PENEL Nicolas, MD principal investigator
Centre Oscar Lambret
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blood and urine, Questionnaire and Telephone interview in people with Angiosarcoma, run by Centre Oscar Lambret at 12 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of identifying incident cases of angiosarcoma liver from the network NetSarc (time frame: At month 36). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2016.