Tumor-educated Platelets in Venous Thromboembolism

Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02739867
• Other study ID #: PLATO-VTE
• Status: Completed
• Start date: June 2016
• Est. completion date: October 2021

Study information

• Verified date: February 2022
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 476
• Est. completion date: October 2021
• Est. primary completion date: October 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Neoplasms
• Thromboembolism
• Venous Thromboembolism

Locations

Country	Name	City	State
Belgium	KU Leuven	Leuven
Canada	Ottawa Hospital	Ottawa
Germany	Dresden University Clinic	Dresden
Italy	Bologna University Hospital	Bologna
Italy	Gabriele D'Annunzio University	Chieti
Italy	University of Padua	Padua
Italy	University of Insubria	Varese
Netherlands	Flevoziekenhuis	Almere
Netherlands	Academic Medical Center	Amsterdam	Noord-Holland
Netherlands	Slotervaartziekenhuis	Amsterdam
Netherlands	VU medical center	Amsterdam
Netherlands	Tergooiziekenhuizen	Hilversum
Netherlands	Leiden University Medical Center	Leiden
Spain	Hospital Universitario Virgen del Rocio	Sevilla

Sponsors (1)

Lead Sponsor	Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Countries where clinical trial is conducted

Belgium,  Canada,  Germany,  Italy,  Netherlands,  Spain, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Any solid or hematological cancer	Adjudicated diagnosis of solid or haematological cancer which is confirmed by histology or cytology, or is unequivocally diagnosed by either imaging or tumour markers	Up to one year following venous thromboembolism
Secondary	Early-stage solid cancer	Early-stage solid cancer, defined as stage I or II solid cancer according to the American Joint Commissee on Cancer criteria.	Up to one year following venous thromboembolism
Secondary	Recurrent venous thromboembolism	Adjudicated recurrent VTE (see full definition in protocol)	Up to one year following venous thromboembolism
Secondary	Major bleeding	Adjudicated major bleeding according to the International Society on Thrombosis and Haemostasis criteria	Up to one year following venous thromboembolism
Secondary	Clinically relevant non-major bleeding	Adjudicated clinically relevant non-major bleeding according to the International Society on Thrombosis and Haemostasis criteria	Up to one year following venous thromboembolism
Secondary	Composite of major bleeding and clinically relevant non-major bleeding		Up to one year following venous thromboembolism
Secondary	All-cause mortality		Up to one year following venous thromboembolism
Secondary	Cancer-related mortality		Up to one year following venous thromboembolism
Secondary	Solid cancer		Up to one year following venous thromboembolism
Secondary	Hematological cancer		Up to one year following venous thromboembolism
Secondary	Composite of solid cancer and lymphoma		Up to one year following venous thromboembolism