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Radiation Impact on Thromboembolic Events

Completed
Conditions
Malignant Neoplasm
Interventions
Biological: Biomarkers assays
Registration Number
NCT02696447
Lead Sponsor
Institut de Cancérologie de la Loire
Brief Summary

The aim of the present study is to determine the frequency and to identify main risk factors for venous thromboembolism of venous thromboembolic complications in a population of cancer patients treated with a curative intent by ionizing radiation.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
450
Inclusion Criteria
  • patient with a solid cancer (all locations) treated with radiation therapy and / or brachytherapy as curative intent
  • to be 18
Exclusion Criteria
  • Patient with metastatic cancer,
  • Patients whose follow-up at 6 months is not possible
  • Patient receiving an anti-coagulative medication (curative doses)
  • Pregnant or breastfeeding women,
  • Person under protection of justice or unable to give consent

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Cancer treated by radiotherapyBiomarkers assaysPatient with a solid cancer (all locations) treated with radiation therapy and/or brachytherapy as curative intent
Primary Outcome Measures
NameTimeMethod
Venous Thromboembolism event6 months

All venous thromboembolism, whether symptomatic or discovered incidentally, objectified (CT angiography, lung scintigraphy, venous Doppler) between J1 of radiation treatment, up to 6 months following discontinuation of radiation treatment

Secondary Outcome Measures
NameTimeMethod
Symptomatic VTE6 months

Symptomatic VTE.

Time of occurrence of VTE6 months

Time of occurrence of VTE

C-reactive protein6 months
Dosage of D-dimer6 months
Complete blood count6 months

Trial Locations

Locations (2)

CH de Roanne

🇫🇷

Roanne, France

Institut de cancérologie Lucien Neuwirth

🇫🇷

Saint-Priest-en-Jarez, France

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