NCT01786889

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

12 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 6, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 8, 2013

Completed
4 months until next milestone

Study Start

First participant enrolled

June 1, 2013

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

July 29, 2016

Status Verified

July 1, 2016

Enrollment Period

3.3 years

First QC Date

February 6, 2013

Last Update Submit

July 28, 2016

Conditions

Angiosarcoma

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (4)

  • Prospective surveillance in France

    At month 36

  • Description of occupational risk factors and environmental

    At month 36

  • Identification of biomarkers associated with human exposure Environmental old and new to vinyl chloride monomer

    At 36 month

  • Assessment of the amount of vinyl chloride monomèredans successive addresses or nearby for cases without occupational exposure identified

    At month 36

Study Arms (1)

Patient with angiosarcoma of the liver

EXPERIMENTAL

Blood and urine collections, questionnaire and telephone interview

Biological: blood and urineBehavioral: QuestionnaireBehavioral: Telephone interview

Interventions

blood and urineBIOLOGICAL

Blood collection and urine collection after consent of the patient

Patient with angiosarcoma of the liver
QuestionnaireBEHAVIORAL

The patient complete the questionnaire alone at home

Patient with angiosarcoma of the liver
Telephone interviewBEHAVIORAL

The patient will be contacted by the CRA for a telephone interview of around one hour

Patient with angiosarcoma of the liver

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Institut Bergonié

Bordeaux, 33076, France

Location

Centre Jean Perrin

Clermont-Ferrand, 63000, France

Location

Centre Georges François

Dijon, 21079, France

Location

Centre Oscar Lambret

Lille, 59020, France

Location

Centre Léon Bérard

Lyon, 69373, France

Location

Hôpital de la TIMONE

Marseille, 13385, France

Location

CRLCC Montpellier

Montpellier, 34298, France

Location

Hopital Tenon

Paris, 75970, France

Location

Institut de Cancérologie Lucien

Saint-Priest-en-Jarez, 42 270, France

Location

CHU Strasbourg

Strasbourg, 67098, France

Location

Institut Claudius Regaud

Toulouse, 31052, France

Location

Chu / Hopital Trousseau

Tours, 37000, France

Location

MeSH Terms

Conditions

Hemangiosarcoma

Interventions

Blood Specimen CollectionUrinationSurveys and QuestionnairesInterviews as Topic

Condition Hierarchy (Ancestors)

SarcomaNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsNeoplasms, Vascular Tissue

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative TechniquesUrinary Tract Physiological PhenomenaReproductive and Urinary Physiological PhenomenaData CollectionEpidemiologic MethodsHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • LE MOAL Joelle, Dr

    Institut de Veille Sanitaire_Département Santé Environnement

    STUDY DIRECTOR

  • PENEL Nicolas, MD

    Centre Oscar Lambret

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 6, 2013

First Posted

February 8, 2013

Study Start

June 1, 2013

Primary Completion

September 1, 2016

Study Completion

January 1, 2017

Last Updated

July 29, 2016

Record last verified: 2016-07

Data Sharing

IPD Sharing
Will not share

Locations

FR(12)