Tumor-educated Platelets in Venous Thromboembolism

NCT ID: NCT02739867

Last Updated: 2022-02-16

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 476 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-06-30
• Study Completion Date: 2021-10-31

Brief Summary

Among patients with a first episode of unprovoked venous thromboembolism (VTE), the contemporary one-year risk of detecting occult cancer is approximately 4% to 7%. Of these cases, 30% to 60% are missed by routine limited screening for cancer. RNA profiling of platelets is a promising, highly accurate biomarker for cancer detection, but its clinical utility in patients with unprovoked VTE is unknown. The objective of the present study is to evaluate the diagnostic accuracy of platelet RNA profiling in detecting occult cancer in patients with unprovoked venous thromboembolism. Secondary objectives include evaluation of other biomarkers for cancer, prediction of bleeding, and prediction of recurrent VTE.

Conditions

Neoplasms; Venous Thromboembolism

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Unprovoked VTE

Patients aged 40 years or older with a first episode of objectively confirmed, symptomatic, unprovoked deep vein thrombosis of the leg (distal or proximal) or pulmonary embolism

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• First episode of objectively confirmed, symptomatic, unprovoked symptomatic pulmonary embolism and/or distal or proximal deep vein thrombosis of the leg
• Age 40 years or older
• Written informed consent

Exclusion Criteria

• known malignant disease prior to VTE defined as a cancer diagnosis or cancer treatment within the past 5 years (of note: suspected but unconfirmed cancer at diagnosis of VTE is allowed);
• trauma or fracture of the leg, surgical procedures, general anesthesia, or immobilization greater than 3 days within previous 3 months;
• previous unprovoked venous thromboembolism;
• known hereditary or acquired thrombophilia;
• current pregnancy or puerperium (up to 3 months postpartum);
• current estrogen therapy.
• Greater than 10 days after VTE diagnosis;
• Inability for blood withdrawal at baseline;
• Inability or refusal to provide written informed consent.

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

OTHER

Sponsor Role: lead

Responsible Party

Harry R. Buller

Professor of Vascular Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Harry Büller, MD, PhD

Role: STUDY_CHAIR

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Locations

KU Leuven

Leuven, , Belgium

Ottawa Hospital

Ottawa, , Canada

Dresden University Clinic

Dresden, , Germany

Bologna University Hospital

Bologna, , Italy

Gabriele D'Annunzio University

Chieti, , Italy

University of Padua

Padua, , Italy

University of Insubria

Varese, , Italy

Academic Medical Center

Amsterdam, North Holland, Netherlands

Flevoziekenhuis

Almere Stad, , Netherlands

Slotervaartziekenhuis

Amsterdam, , Netherlands

VU medical center

Amsterdam, , Netherlands

Tergooiziekenhuizen

Hilversum, , Netherlands

Leiden University Medical Center

Leiden, , Netherlands

Hospital Universitario Virgen del Rocio

Seville, , Spain

Countries

Belgium; Canada; Germany; Italy; Netherlands; Spain

References

Best MG, Sol N, Kooi I, Tannous J, Westerman BA, Rustenburg F, Schellen P, Verschueren H, Post E, Koster J, Ylstra B, Ameziane N, Dorsman J, Smit EF, Verheul HM, Noske DP, Reijneveld JC, Nilsson RJA, Tannous BA, Wesseling P, Wurdinger T. RNA-Seq of Tumor-Educated Platelets Enables Blood-Based Pan-Cancer, Multiclass, and Molecular Pathway Cancer Diagnostics. Cancer Cell. 2015 Nov 9;28(5):666-676. doi: 10.1016/j.ccell.2015.09.018. Epub 2015 Oct 29.

Reference Type: BACKGROUND

PMID: 26525104 (View on PubMed)

Other Identifiers

PLATO-VTE

Identifier Type: -

Identifier Source: org_study_id