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Tumor-educated Platelets in Venous Thromboembolism

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02739867
Recruitment Status : Completed
First Posted : April 15, 2016
Last Update Posted : February 16, 2022
Sponsor:
Information provided by (Responsible Party):
Harry R. Buller, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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.

Condition or disease
Neoplasms Venous Thromboembolism

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Study Type : Observational
Actual Enrollment : 476 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Platelet RNA Profiling to Detect Occult Cancer in Patients With Unprovoked Venous Thromboembolism
Study Start Date : June 2016
Actual Primary Completion Date : October 2020
Actual Study Completion Date : October 2021

Group/Cohort
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



Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Biospecimen Retention:   Samples With DNA
Platelet pellet, EDTA plasma, citrated plasma, and cell-free DNA


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02739867


Locations
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Belgium
KU Leuven
Leuven, Belgium
Canada
Ottawa Hospital
Ottawa, Canada
Germany
Dresden University Clinic
Dresden, Germany
Italy
Bologna University Hospital
Bologna, Italy
Gabriele D'Annunzio University
Chieti, Italy
University of Padua
Padua, Italy
University of Insubria
Varese, Italy
Netherlands
Academic Medical Center
Amsterdam, Noord-Holland, Netherlands, 1105AZ
Flevoziekenhuis
Almere, Netherlands
Slotervaartziekenhuis
Amsterdam, Netherlands
VU medical center
Amsterdam, Netherlands
Tergooiziekenhuizen
Hilversum, Netherlands
Leiden University Medical Center
Leiden, Netherlands
Spain
Hospital Universitario Virgen del Rocio
Sevilla, Spain
Sponsors and Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Investigators
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Study Chair: Harry Büller, MD, PhD Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Publications:
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Responsible Party: Harry R. Buller, Professor of Vascular Medicine, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier: NCT02739867    
Other Study ID Numbers: PLATO-VTE
First Posted: April 15, 2016    Key Record Dates
Last Update Posted: February 16, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Harry R. Buller, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):
occult cancer
venous thromboembolism
tumor-educated platelets
platelet RNA profiling
early diagnosis
screening
Additional relevant MeSH terms:
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Thromboembolism
Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases