Radiation Impact on Thromboembolic Events

NCT ID: NCT02696447

Last Updated: 2020-01-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

450 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-06-14

Study Completion Date

2019-11-25

Brief Summary

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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

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Conditions

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Malignant Neoplasm

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cancer treated by radiotherapy

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

Biomarkers assays

Intervention Type BIOLOGICAL

D-Dimer assays, C-reactive protein, blood platelets assays

Interventions

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Biomarkers assays

D-Dimer assays, C-reactive protein, blood platelets assays

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role collaborator

CH Roanne

UNKNOWN

Sponsor Role collaborator

Institut de Cancérologie de la Loire

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CH de Roanne

Roanne, , France

Site Status

Institut de cancérologie Lucien Neuwirth

Saint-Priest-en-Jarez, , France

Site Status

Countries

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France

References

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Daguenet E, Maison M, Tinquaut F, Giroux EA, Bertoletti L, Suchaud JP, Rancoule C, Guy JB, Magne N. Venous thromboembolism and radiation therapy: The final radiation-induced thrombosis study analysis. Cancer Med. 2022 Apr;11(8):1753-1762. doi: 10.1002/cam4.4559. Epub 2022 Feb 24.

Reference Type DERIVED
PMID: 35199492 (View on PubMed)

Other Identifiers

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2015-09

Identifier Type: -

Identifier Source: org_study_id

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