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Completed

NCT Number: NCT02739867

Tumor-educated Platelets in Venous Thromboembolism

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.

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Key information

Conditions

Neoplasms Cardiovascular Diseases Disease Embolism and Thrombosis Pathologic Processes Pathological Conditions, Signs and Symptoms Thromboembolism Vascular Diseases Venous Thromboembolism

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

KU Leuven, Leuven, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Any solid or hematological cancer

    Time frame: Up to one year following venous thromboembolism

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

Secondary outcomes

  1. Early-stage solid cancer

    Time frame: Up to one year following venous thromboembolism

    Early-stage solid cancer, defined as stage I or II solid cancer according to the American Joint Commissee on Cancer criteria.

  2. Recurrent venous thromboembolism

    Time frame: Up to one year following venous thromboembolism

    Adjudicated recurrent VTE (see full definition in protocol)

  3. Major bleeding

    Time frame: Up to one year following venous thromboembolism

    Adjudicated major bleeding according to the International Society on Thrombosis and Haemostasis criteria

  4. Clinically relevant non-major bleeding

    Time frame: Up to one year following venous thromboembolism

    Adjudicated clinically relevant non-major bleeding according to the International Society on Thrombosis and Haemostasis criteria

  5. Composite of major bleeding and clinically relevant non-major bleeding

    Time frame: Up to one year following venous thromboembolism

  6. All-cause mortality

    Time frame: Up to one year following venous thromboembolism

  7. Cancer-related mortality

    Time frame: Up to one year following venous thromboembolism

  8. Solid cancer

    Time frame: Up to one year following venous thromboembolism

  9. Hematological cancer

    Time frame: Up to one year following venous thromboembolism

  10. Composite of solid cancer and lymphoma

    Time frame: Up to one year following venous thromboembolism

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

Platelet RNA Profiling to Detect Occult Cancer in Patients With Unprovoked Venous Thromboembolism

Important dates

Study start
2016
Primary completion
2020
Study completion
2021
First posted
Apr 15, 2016
Registry last updated
Feb 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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