ThromboembolismCISTRONNCT03893461
Coagulation System In STereotactic Radiotherapy Of NSCLC
An observational study of Thromboembolism and Lung Cancer, run by Odense University Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thromboembolism, Lung Cancer, NSCLC
- What is being tested?
- x
- Type of treatment
- Surgery or procedure
- How many people
- 110 participants
- Where
- 1 siteDenmark
- Study dates
- 26 Mar 2019to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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)
Who may be able to join
- Age > 18 years
- Planned stereotactic body radiation therapy of lung cancer
Who cannot join
- Inability to provide informed consent
- Venous thrombosis within the last three months
- Active cancer within the previous year except for lung cancer
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Oncology, Odense University Hospital
Odense C, 5000
About this study
Official title: Impact of Stereotactic Body Radiation Therapy on the Coagulation System in Patients With Non-small Cell Lung Cancer
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.
Read the 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.
- Conditions
- Thromboembolism, Lung Cancer, NSCLC, Radiotherapy; Complications
- Being tested
- x
- Medical subject headings
- Thromboembolism, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
xRadiation
Stereotactic body radiation therapy for localized NSCLC
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in coagulation
endogenous thrombin
Measured: From start of SBRT to end and 5 weeks after SBRT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2019
- Study start26 Mar 2019
- Primary completion30 Jun 2021
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThromboembolismStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefan Starup Jeppesen, Odense University Hospital
- Investigators
- Stefan S Jeppesen, MD, PhD, Principal investigator, Department of Oncology, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03893461
- Sponsor's protocol ID
- S-20180109
- Acronym
- CISTRON
- Status last verified
- Jul 2021
- First submitted
- 26 Mar 2019
- Last updated
- 22 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Stereotactic Body Radiation Therapy on the Coagulation System in Patients With Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT03893461
- Acronym / sponsor ID
- CISTRON / S-20180109
- Conditions
- Thromboembolism, Lung Cancer, NSCLC, Radiotherapy; Complications
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Study start
- 26 Mar 2019 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 28 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (2 listed)
- Age > 18 years
- Planned stereotactic body radiation therapy of lung cancer
Key exclusion criteria (3 listed)
- Inability to provide informed consent
- Venous thrombosis within the last three months
- Active cancer within the previous year except for lung cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| xStereotactic body radiation therapy for localized NSCLC | Radiation | – |
Primary outcome
Changes in coagulation
Time frame: From start of SBRT to end and 5 weeks after SBRT
endogenous thrombin
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2021.
- Individual participant dataSharing planned: Undecided
Related trials for Thromboembolism
Not yet recruitingPhase 3
TicAgreLor Versus Placebo to Prevent Cerebral ISCHemia in anEuRysmal Low Grade SAH A Double Blinded Randomised Controlled Study
Subarachnoid Hemorrhage, Aneurysmal, Brain Ischemia
RecruitingPhase 3
REGN7508 Versus Apixaban and Enoxaparin for Thromboprophylaxis After Total Knee Arthroplasty in Adults
Venous Thromboembolism (VTE)
RecruitingPhase 3
Treatment and Secondary Prevention of Venous Thromboembolism (VTE) in Adult Participants With Solid and Hematologic Cancers
Venous Thromboembolism (VTE)
RecruitingPhase 3
REGN7508 in Adult Participants for Prevention of Cancer-Associated Thrombosis
Cancer-Associated Thrombosis (CAT)
RecruitingPhase 3
REGN7508 Versus Acetylsalicylic Acid (ASA) for Venous Thromboprophylaxis After Total Knee Arthroplasty in Adult Participants
Symptomatic Venous Thromboembolism (VTE)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefan S Jeppesen, MD, PhD principal investigator
Department of Oncology, Odense University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thromboembolism and Lung Cancer, run by Odense University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in coagulation (time frame: From start of SBRT to end and 5 weeks after SBRT). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2021.