NCT03893461

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
110

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 26, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

March 26, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 28, 2019

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

July 22, 2021

Status Verified

July 1, 2021

Enrollment Period

2.3 years

First QC Date

March 26, 2019

Last Update Submit

July 21, 2021

Conditions

ThromboembolismLung CancerNSCLCRadiotherapy; Complications

Outcome Measures

Primary Outcomes (1)

  • Changes in coagulation

    endogenous thrombin

    From start of SBRT to end and 5 weeks after SBRT

Interventions

xRADIATION

Stereotactic body radiation therapy for localized NSCLC

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

A prospective study of 100 consecutively included lung cancer patients receiving stereotactic body radiation therapy. As standard treatment, which is considered for best practice, the patients receive: 1. 66 Gy/ 3 fractions (F) (new primary peripheral lung cancer), or 2. 50 Gy/ 5 F (new primary central lung cancer), or 3. 45 Gy/ 3 F (peripheral lung cancer relapse after initial surgery or stereotactic body radiation therapy)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Oncology, Odense University Hospital

Odense C, 5000, Denmark

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood sample collection for biobank

MeSH Terms

Conditions

ThromboembolismLung Neoplasms

Condition Hierarchy (Ancestors)

Embolism and ThrombosisVascular DiseasesCardiovascular DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Stefan S Jeppesen, MD, PhD

    Department of Oncology, Odense University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

March 26, 2019

First Posted

March 28, 2019

Study Start

March 26, 2019

Primary Completion

June 30, 2021

Study Completion

December 31, 2022

Last Updated

July 22, 2021

Record last verified: 2021-07

Locations

DK(1)