NCT05256329

Brief Summary

Cancer is associated with an increased incidence of thrombosis and thromboembolic events are one of the leading causes of morbidity and mortality in this population. The main consideration has been given to venous thromboembolic events (VTEs); arterial thrombotic events (ATEs) have more recently been recognized to precede cancer diagnosis and/or follow it as a serious complication. Thus, while plausible, the relationship between cancer and arterial thrombosis is less well established than for VTE. We sought to undertake the COMPASS-ARTeCAT (Comparison of Methods for thromboembolic risk assessment with clinical Perceptions and AwareneSS in real life patients- Arterial Cancer Associated Thrombosis) study aiming to identify the most clinically relevant clinical predictors of arterial thrombosis in ambulatory patients with specific types of cancer who are going to start or have already started anticancer treatment. This study aims to evaluate the incidence and the association between arterial thromboembolism and occult cancer. Moreover, this study will provide a risk assessment model (RAM) for arterial thrombosis applicable to cancer patients at any time after anticancer therapy initiation

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
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2021

Longer than P75 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

Study Start

First participant enrolled

January 1, 2021

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 16, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 25, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2023

Completed
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

February 25, 2022

Status Verified

February 1, 2022

Enrollment Period

2.2 years

First QC Date

February 16, 2022

Last Update Submit

February 16, 2022

Conditions

Cancer

Outcome Measures

Primary Outcomes (1)

  • Composite of symptomatic arterial thromboembolism (any inpatient diagnosis)

    a. acute coronary syndrome (ACS) including ST- elevation myocardial infarction (STEMI), non-ST elevation MI (NSTEMI) or unstable angina (UA), b. transient ischemic attack (TIA) or ischemic stroke or c. other arterial thromboembolism (systemic embolism or mesenteric ischemia) defined according to the respective diagnostic criteria and recommendations.

    2 years

Secondary Outcomes (2)

  • Peripheral arterial disease

    2 years

  • Hypertension

    2 years

Study Arms (1)

Oncology patients

Patients suffering from specific solid cancers or hematological malignancies

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Ambulatory cancer patients, with histologically confirmed solid cancer (breast, lung, gastric, colorectal, pancreatic, ovarian, prostate, or bladder cancer) or specific hematologic malignancy (Hodgkin and non-Hodgkin lymphoma or multiple myeloma). Patients diagnosed with multiple primary cancers during the study period will be assigned to the cancer type diagnosed first.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Konstantinos Toutouzas

Athens, Greece

RECRUITING

Related Publications (1)

  • 1. Abdol Razak, N., Jones, G., Bhandari, M., Berndt, M. & Metharom, P. Cancer-Associated Thrombosis: An Overview of Mechanisms, Risk Factors, and Treatment. Cancers (Basel). 10, 380 (2018). 2. Blann, A. D. & Dunmore, S. Arterial and venous thrombosis in cancer patients. Cardiol. Res. Pract. 2011, 394740 (2011). 3. Di Nisio, M. et al. Arterial thrombosis in ambulatory cancer patients treated with chemotherapy. Thromb. Res. 127, 382-383 (2011). 4. Gerotziafas, G. T., Papageorgiou, L., Salta, S., Nikolopoulou, K. & Elalamy, I. Updated clinical models for VTE prediction in hospitalized medical patients. Thromb. Res. 164, S62-S69 (2018). 5. De Stefano, V. Arterial thrombosis and cancer: the neglected side of the coin of Trousseau syndrome. Haematologica 103, 1419-1421 (2018). 6. Aronson, D. & Brenner, B. Arterial thrombosis and cancer. Thromb. Res. 164, S23-S28 (2018). 7. Tuzovic, M. et al. Arterial Thrombosis in Patients with Cancer. Curr. Treat. Options Cardiovasc. Med. 20, 40 (2018). 8. Frere, C., Martin-Toutain, I., Thuny, F. & Bonello, L. Risk of Arterial Thrombosis in Cancer Patients. J. Am. Coll. Cardiol. 71, 260 (2018). 9. Hung, Y.-S. et al. Incidence, Risk Factors, and Outcomes of Arterial Thromboembolism in Patients with Pancreatic Cancer Following Palliative Chemotherapy. Cancers (Basel). 10, (2018). 10. Navi, B. B. et al. Risk of Arterial Thromboembolism in Patients With Cancer. J. Am. Coll. Cardiol. 70, 926-938 (2017). 11. Oren, O. & Herrmann, J. Arterial events in cancer patients-the case of acute coronary thrombosis. J. Thorac. Dis. 10, S4367 (2018). 12. Grilz, E. et al. Frequency, risk factors, and impact on mortality of arterial thromboembolism in patients with cancer. Haematologica 103, 1549-1556 (2018). 13. Baron, J. A., Gridley, G., Weiderpass, E., Nyren, O. & Linet, M. Venous thromboembolism and cancer. Lancet 351, 1077-1080 (1998). 14. Gregson, J. et al. Cardiovascular Risk Factors Associated With Venous Thromboembolism. JAMA Cardiol. 4, 163 (2019). 15. Abdel-Razeq, H. et al. Thromboembolic events in cancer patients on active treatment with cisplatin-based chemotherapy: another look! Thromb. J. 16, 2 (2018). 16. Gerotziafas, G. T. et al. A Predictive Score for Thrombosis Associated with Breast, Colorectal, Lung, or Ovarian Cancer: The Prospective COMPASS-Cancer-Associated Thrombosis Study. Oncologist 22, 1222-1231 (2017). 17. Antic, D. et al. Development and validation of multivariable predictive model for thromboembolic events in lymphoma patients. Am. J. Hematol. 91, 1014-1019 (2016). 18. Boura, P. et al. PO-53 - Prospective evaluation of risk assessment models and biological markers of hypercoagulability for the identification of high VTE risk patients with lung adenocarcinoma. The ROADMAP study. Thromb. Res. 140, S196 (2016). 19. Anand, L. N. et al. External validation of the COMPASS-Cancer Associated Thrombosis Study: A predictive score to identify patients with solid tumors on treatment who are at risk for venous thromboembolism. J. Clin. Oncol. 37, e18005-e18005 (2019). 20. WHO | International Classification of Diseases for Oncology, 3rd Edition (ICD-O-3). WHO (2019). 21. Austin, P. C. & Steyerberg, E. W. Events per variable (EPV) and the relative performance of different strategies for estimating the out-of-sample validity of logistic regression models. Stat. Methods Med. Res. 26, 796 (2017).

    BACKGROUND

MeSH Terms

Conditions

Neoplasms

Central Study Contacts

Konstantinos KT Toutouzas, PhD

CONTACT

6932289519ktoutouz@gmail.com

Maria MD Drakopoulou, PhD

CONTACT

6945991022mdrakopoulou@hotmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Cardiology

Study Record Dates

First Submitted

February 16, 2022

First Posted

February 25, 2022

Study Start

January 1, 2021

Primary Completion

April 1, 2023

Study Completion

December 1, 2025

Last Updated

February 25, 2022

Record last verified: 2022-02

Locations

GR(1)