CISTRON: Coagulation System In STereotactic Radiotherapy Of NSCLC

• Sponsor: Odense University Hospital (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT03893461
• Collaborator: (none)
• Enrollment: 110
• Location: 1
• Anticipated Duration (Months): 45.2
• Patients Per Site Per Month: 2.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Thromboembolism; Lung Cancer; NSCLC; Radiotherapy; Complications	Radiation: x

Detailed Description

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 110 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Impact of Stereotactic Body Radiation Therapy on the Coagulation System in Patients With Non-small Cell Lung Cancer
• Actual Study Start Date: Mar 26, 2019
• Actual Primary Completion Date: Jun 30, 2021
• Anticipated Study Completion Date: Dec 31, 2022

Outcome Measures

Primary Outcome Measures

1. Changes in coagulation [From start of SBRT to end and 5 weeks after SBRT]

   endogenous thrombin

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Oncology, Odense University Hospital	Odense C		Denmark	5000

Sponsors and Collaborators

• Odense University Hospital

Investigators

• Principal Investigator: Stefan S Jeppesen, MD, PhD, Department of Oncology, Odense University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Stefan Starup Jeppesen, MD, PhD, Odense University Hospital
• ClinicalTrials.gov Identifier: NCT03893461
• Other Study ID Numbers: S-20180109
• First Posted: Mar 28, 2019
• Last Update Posted: Jul 22, 2021
• Last Verified: Jul 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Lung Neoplasms; Thromboembolism

Study Results

No Results Posted as of Jul 22, 2021