To evaluate the influence of anticoagulant treatment on the platelet mRNA profile in patients in whom anticoagulation is initiated.
ID
Source
Brief title
Condition
- Miscellaneous and site unspecified neoplasms benign
- Embolism and thrombosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Correlation between the platelet mRNA profile, expressed as mean
log2-transformed counts per million, before anticoagulation and during
anticoagulation.
Secondary outcome
Differences in plasma levels of coagulation markers before and during
anticoagulation, including D-dimer and endogenous thrombin potential.
Background summary
Platelet mRNA sequencing has recently been introduced as a promising biomarker
for cancer.1 The concept revolves around the alteration of the platelet mRNA
profile in the presence of cancer through several mechanisms: (1) transfer of
oncogenic mRNA to platelets mediated by extracellular vesicles; (2) specific
splicing of precursor mRNA in platelets induced by platelet activation; (3)
splice events in response to signals released by cancer cells, and (4) direct
mRNA ingestion by platelets. Following these events, the platelets are then
referred to as *tumour-educated platelets*.
The mRNA profile of tumour-educated platelets appears to be
significantly different from the profile of healthy donors, which potentially
allows for its use as a pan-cancer diagnostic tool. In a first study of 228
patients with various cancer types and 55 healthy donors, platelet mRNA
sequencing was associated with a sensitivity of 97% and a specificity of 94%
for detecting cancer (Best et al, Cancer Cell 2015).
Recently, the PLATO-VTE study was initiated to evaluate the diagnostic
accuracy of platelet mRNA sequencing to detect occult cancer in patients with
unprovoked venous thromboembolism (VTE) (NL57256.018.16; AMC METC 2016_110).
For the interpretation of the test results, it is crucial that we know the
potential influence of anticoagulant therapy on the test.
Study objective
To evaluate the influence of anticoagulant treatment on the platelet mRNA
profile in patients in whom anticoagulation is initiated.
Study design
This is an observational, prospective cohort study that will enroll patients in
whom anticoagulation is initiated, including those with new onset atrial
fibrillation and venous thromboembolism. A total of 12.7 cc blood will be drawn
in three tubes before initiation of anticoagulation and at 10±3 days (see
Appendix 1 for details). Blood will be used for testing of coagulation markers
and platelet mRNA profiling.
Study burden and risks
The burden for patients consists of two blood withdrawals of 12.7cc; one at
baseline and one after a minimum of 10 days.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
- Age 18 years or older
- Objectively confirmed, new onset atrial fibrillation or acute VTE (deep vein
thrombosis or pulmonary embolism)
Exclusion criteria
- Anticoagulant therapy at the time of the first blood withdrawal
- Inability for blood withdrawal;
- Inability or refusal to provide written informed consent
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL60989.018.17 |