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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02696447
Other study ID # 2015-09
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 14, 2016
Est. completion date November 25, 2019

Study information

Verified date January 2020
Source Institut de Cancérologie de la Loire
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 450
Est. completion date November 25, 2019
Est. primary completion date December 24, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

Biological:
Biomarkers assays
D-Dimer assays, C-reactive protein, blood platelets assays

Locations

Country Name City State
France CH de Roanne Roanne
France Institut de cancérologie Lucien Neuwirth Saint-Priest-en-Jarez

Sponsors (3)

Lead Sponsor Collaborator
Institut de Cancérologie de la Loire Centre Hospitalier Universitaire de Saint Etienne, CH Roanne

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Venous Thromboembolism event 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 6 months
Secondary Dosage of D-dimer 6 months
Secondary C-reactive protein 6 months
Secondary Complete blood count 6 months
Secondary Time of occurrence of VTE Time of occurrence of VTE 6 months
Secondary Symptomatic VTE Symptomatic VTE. 6 months
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