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Tumor-educated Platelets in Venous Thromboembolism

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ClinicalTrials.gov Identifier: NCT02739867
Recruitment Status : Recruiting
First Posted : April 15, 2016
Last Update Posted : November 14, 2017
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

Study Type : Observational
Estimated Enrollment : 462 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
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2019

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


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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


Contacts
Contact: Noémie Kraaijpoel, MD 0031205667050 n.kraaijpoel@amc.nl
Contact: Nick van Es, MD n.vanes@amc.nl

Locations
United States, Oklahoma
University of Oklahoma Health Sciences Centre Not yet recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Gary Raskob         
Belgium
KU Leuven Recruiting
Leuven, Belgium
Contact: Peter Verhamme         
Canada
Ottawa Hospital Recruiting
Ottawa, Canada
Contact: Marc Carrier         
Germany
Dresden University Clinic Not yet recruiting
Dresden, Germany
Contact: Jan Beyer-Westendorf, MD, PhD         
Italy
Bologna University Hospital Not yet recruiting
Bologna, Italy
Contact: Benilde Cosmi         
Gabriele D'Annunzio University Recruiting
Chieti, Italy
Contact: Marcello Di Nisio         
University of Padua Not yet recruiting
Padua, Italy
Contact: Andrea Piccioli         
University of Insubria Recruiting
Varese, Italy
Contact: Walter Ageno         
Netherlands
Academic Medical Center Recruiting
Amsterdam, Noord-Holland, Netherlands, 1105AZ
Contact: Noémie Kraaijpoel, MSc       n.kraaijpoel@amc.nl   
Contact: Nick van Es, MD       n.vanes@amc.nl   
Slotervaartziekenhuis Recruiting
Amsterdam, Netherlands
Contact: Hans-Martin Otten         
VU medical center Recruiting
Amsterdam, Netherlands
Contact: Mark Kramer         
Tergooiziekenhuizen Recruiting
Hilversum, Netherlands
Contact: Pieter W Kamphuisen, MD, PhD         
Leiden University Medical Center Recruiting
Leiden, Netherlands
Contact: Erik Klok         
Spain
Hospital Universitario Virgen del Rocio Recruiting
Sevilla, Spain
Contact: Luis Jara-Palomares, MD, PhD         
Sponsors and Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Investigators
Study Chair: Harry Büller, MD, PhD Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Publications:
Responsible Party: Harry R. Buller, Professor of Vascular Medicine, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier: NCT02739867     History of Changes
Other Study ID Numbers: PLATO-VTE
First Posted: April 15, 2016    Key Record Dates
Last Update Posted: November 14, 2017
Last Verified: November 2017
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:
Thromboembolism
Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases