Tumor-educated Platelets in Venous Thromboembolism

NCT02739867 | Completed

• 1 other identifier: PLATO-VTE
• Study Type: observational
• Target: 476
• Locations: 6 countries
• Sites: 14

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

Keywords

occult cancer; venous thromboembolism; tumor-educated platelets; platelet RNA profiling; early diagnosis; screening

Outcome Measures

Primary Outcomes (1)

• Any solid or hematological cancer

  Adjudicated diagnosis of solid or haematological cancer which is confirmed by histology or cytology, or is unequivocally diagnosed by either imaging or tumour markers

  Up to one year following venous thromboembolism

Secondary Outcomes (10)

• Early-stage solid cancer

  Up to one year following venous thromboembolism

• Recurrent venous thromboembolism

  Up to one year following venous thromboembolism

• Major bleeding

  Up to one year following venous thromboembolism

• Clinically relevant non-major bleeding

  Up to one year following venous thromboembolism

• Composite of major bleeding and clinically relevant non-major bleeding

  Up to one year following venous thromboembolism

Study Arms (1)

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

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Consecutive patients of 40 years or older with a first episode of objectively confirmed, symptomatic unprovoked distal or proximal deep vein thrombosis or pulmonary embolism.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead

Study Sites (14)

KU Leuven

Leuven, Belgium

Location

Ottawa Hospital

Ottawa, Canada

Location

Dresden University Clinic

Dresden, Germany

Location

Bologna University Hospital

Bologna, Italy

Location

Gabriele D'Annunzio University

Chieti, Italy

Location

University of Padua

Padua, Italy

Location

University of Insubria

Varese, Italy

Location

Academic Medical Center

Amsterdam, North Holland, 1105AZ, Netherlands

Location

Flevoziekenhuis

Almere Stad, Netherlands

Location

Slotervaartziekenhuis

Amsterdam, Netherlands

Location

VU medical center

Amsterdam, Netherlands

Location

Tergooiziekenhuizen

Hilversum, Netherlands

Location

Leiden University Medical Center

Leiden, Netherlands

Location

Hospital Universitario Virgen del Rocio

Seville, Spain

Location

Related Publications (1)

• 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.

  PMID: 26525104 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Platelet pellet, EDTA plasma, citrated plasma, and cell-free DNA

MeSH Terms

Conditions

Neoplasms; Venous Thromboembolism; Disease

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Harry Büller, MD, PhD

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

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Vascular Medicine

Study Record Dates

• First Submitted: April 12, 2016
• First Posted: April 15, 2016
• Study Start: June 1, 2016
• Primary Completion: October 1, 2020
• Study Completion: October 1, 2021
• Last Updated: February 16, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1); ES (1); BE (1); IT (4); NL (6); DE (1)