Tumor-educated Platelets in Venous Thromboembolism

Sponsor

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

Overall Status

Completed

CT.gov ID

NCT02739867

Collaborator

(none)

476

Enrollment

Locations

Duration (Months)

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

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	Intervention/Treatment	Phase
Neoplasms Venous Thromboembolism

Study Design

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 :

Jun 1, 2016

Actual Primary Completion Date :

Oct 1, 2020

Actual Study Completion Date :

Oct 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

Any solid or hematological cancer [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

Early-stage solid cancer [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.
Recurrent venous thromboembolism [Up to one year following venous thromboembolism]
Adjudicated recurrent VTE (see full definition in protocol)
Major bleeding [Up to one year following venous thromboembolism]
Adjudicated major bleeding according to the International Society on Thrombosis and Haemostasis criteria
Clinically relevant non-major bleeding [Up to one year following venous thromboembolism]
Adjudicated clinically relevant non-major bleeding according to the International Society on Thrombosis and Haemostasis criteria
Composite of major bleeding and clinically relevant non-major bleeding [Up to one year following venous thromboembolism]
All-cause mortality [Up to one year following venous thromboembolism]
Cancer-related mortality [Up to one year following venous thromboembolism]
Solid cancer [Up to one year following venous thromboembolism]
Hematological cancer [Up to one year following venous thromboembolism]
Composite of solid cancer and lymphoma [Up to one year following venous thromboembolism]

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	KU Leuven	Leuven		Belgium
2	Ottawa Hospital	Ottawa		Canada
3	Dresden University Clinic	Dresden		Germany
4	Bologna University Hospital	Bologna		Italy
5	Gabriele D'Annunzio University	Chieti		Italy
6	University of Padua	Padua		Italy
7	University of Insubria	Varese		Italy
8	Academic Medical Center	Amsterdam	Noord-Holland	Netherlands	1105AZ
9	Flevoziekenhuis	Almere		Netherlands
10	Slotervaartziekenhuis	Amsterdam		Netherlands
11	VU medical center	Amsterdam		Netherlands
12	Tergooiziekenhuizen	Hilversum		Netherlands
13	Leiden University Medical Center	Leiden		Netherlands
14	Hospital Universitario Virgen del Rocio	Sevilla		Spain