Radiation Impact on Thromboembolic Events (RIT)

January 28, 2020 updated by: Institut de Cancérologie de la Loire

Radiation Therapy and Venous Thromboembolic Events

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

450

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Roanne, France
        • CH de Roanne
      • Saint-Priest-en-Jarez, France, 42270
        • Institut de Cancérologie Lucien Neuwirth

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patient with a solid (all locations) treated with radiation therapy and / or brachytherapy as curative intent

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cancer treated by radiotherapy
Patient with a solid cancer (all locations) treated with radiation therapy and/or brachytherapy as curative intent
Biological: Biomarkers assays
D-Dimer assays, C-reactive protein, blood platelets assays

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Venous Thromboembolism event
Time Frame: 6 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
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
C-reactive protein
Time Frame: 6 months
6 months
Complete blood count
Time Frame: 6 months
6 months
Dosage of D-dimer
Time Frame: 6 months
6 months
Time of occurrence of VTE
Time Frame: 6 months
Time of occurrence of VTE
6 months
Symptomatic VTE
Time Frame: 6 months
Symptomatic VTE.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut de Cancérologie de la Loire

Collaborators

Centre Hospitalier Universitaire de Saint Etienne
CH Roanne

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 14, 2016

Primary Completion (Actual)

December 24, 2018

Study Completion (Actual)

November 25, 2019

Study Registration Dates

First Submitted

February 25, 2016

First Submitted That Met QC Criteria

February 25, 2016

First Posted (Estimate)

March 2, 2016

Study Record Updates

Last Update Posted (Actual)

January 29, 2020

Last Update Submitted That Met QC Criteria

January 28, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-09

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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