Clinical trial NCT02739867: Tumor-educated Platelets in Venous Thromboembolism
Official title: Platelet RNA Profiling to Detect Occult Cancer in Patients With Unprovoked Venous Thromboembolism
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neoplasms
Venous Thromboembolism
Keywords: occult cancer
venous thromboembolism
tumor-educated platelets
platelet RNA profiling
early diagnosis
screening
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
First posted: 2016-04-15
Enrollment: 476
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


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.

Primary outcomes:
measure: Any solid or hematological cancer
timeFrame: Up to one year following venous thromboembolism
Secondary outcomes:
measure: Early-stage solid cancer
timeFrame: Up to one year following venous thromboembolism
measure: Recurrent venous thromboembolism
timeFrame: Up to one year following venous thromboembolism
measure: Major bleeding
timeFrame: Up to one year following venous thromboembolism
measure: Clinically relevant non-major bleeding
timeFrame: Up to one year following venous thromboembolism
measure: Composite of major bleeding and clinically relevant non-major bleeding
timeFrame: Up to one year following venous thromboembolism
measure: All-cause mortality
timeFrame: Up to one year following venous thromboembolism
measure: Cancer-related mortality
timeFrame: Up to one year following venous thromboembolism
measure: Solid cancer
timeFrame: Up to one year following venous thromboembolism
measure: Hematological cancer
timeFrame: Up to one year following venous thromboembolism
measure: Composite of solid cancer and lymphoma
timeFrame: Up to one year following venous thromboembolism
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: KU Leuven
city: Ottawa
country: Canada
facility: Ottawa Hospital
city: Dresden
country: Germany
facility: Dresden University Clinic
city: Bologna
country: Italy
facility: Bologna University Hospital
city: Chieti
country: Italy
facility: Gabriele D'Annunzio University
city: Padua
country: Italy
facility: University of Padua
city: Varese
country: Italy
facility: University of Insubria
city: Amsterdam
country: Netherlands
facility: Academic Medical Center
state: Noord-Holland
city: Almere
country: Netherlands
facility: Flevoziekenhuis
city: Amsterdam
country: Netherlands
facility: Slotervaartziekenhuis
city: Amsterdam
country: Netherlands
facility: VU medical center
city: Hilversum
country: Netherlands
facility: Tergooiziekenhuizen
city: Leiden
country: Netherlands
facility: Leiden University Medical Center
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio
Study officials:
affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
name: Harry Büller, MD, PhD
role: STUDY_CHAIR
References:
citation: 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.