Coagulation System In STereotactic Radiotherapy Of NSCLC

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

UNKNOWN

Total Enrollment

110 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-03-26

Study Completion Date

2022-12-31

Brief Summary

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The risk of thromboembolism is elevated in lung cancer patients. The present project investigates whether stereotactic body radiation therapy (SBRT) further increases the risk of thromboembolic disease in lung cancer patients.

If coagulation is activated by SBRT, this study could form the basis of new clinical trials investigating whether lung cancer patients may benefit from thromboprophylaxis during and after stereotactic body radiation therapy.

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Detailed Description

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In this study, the patients will have blood samples drawn three times (prior to start of stereotactic body radiation therapy, immediately after stereotactic body radiation therapy completion, four to six weeks after completing stereotactic body radiation therapy). The blood sample at the completion of stereotactic body radiation therapy is an extra compared to normal gathering of blood samples of patients with NSCLC treated with stereotactic body radiation therapy. Also extra glasses with blood will be gathered at each blood sample for storage in a biobank in order to be able to make future analysis on this material.

There is a minimal risk of developing infection or hematoma in connection with blood sampling but we consider this risk to be negligible. The total volume of 120 ml blood drawn over a period of 6 weeks is an inconsiderable risk for the patient.

Conditions

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Thromboembolism Lung Cancer NSCLC Radiotherapy; Complications

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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x

Stereotactic body radiation therapy for localized NSCLC

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

* Age \> 18 years
* Planned stereotactic body radiation therapy of lung cancer

Exclusion Criteria

* Inability to provide informed consent
* Venous thrombosis within the last three months
* Active cancer within the previous year except for lung cancer

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No