NeoplasmsNCT02739867
Tumor-educated Platelets in Venous Thromboembolism
An observational study of Neoplasms and Venous Thromboembolism, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 14 sites in 6 countries.
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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Neoplasms, Venous Thromboembolism
- How many people
- 476 participants
- Where
- 14 sitesin 6 countries
- Study dates
- Jun 2016to Oct 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Show all 9Show fewer
- Greater than 10 days after VTE diagnosis;
- Inability for blood withdrawal at baseline;
- Inability or refusal to provide written informed consent.
Trial locations and contacts
14 sites in 6 countries.
14 sites in 6 countries
Netherlands6 sites
Flevoziekenhuis
Almere Stad
Academic Medical Center
Amsterdam, North Holland, 1105AZ
Slotervaartziekenhuis
Amsterdam
VU medical center
Amsterdam
Tergooiziekenhuizen
Hilversum
Leiden University Medical Center
Leiden
Italy4 sites
Bologna University Hospital
Bologna
Gabriele D'Annunzio University
Chieti
University of Padua
Padua
University of Insubria
Varese
About this study
Official title: Platelet RNA Profiling to Detect Occult Cancer in Patients With Unprovoked Venous Thromboembolism
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.
- Conditions
- Neoplasms, Venous Thromboembolism
- Keywords
- occult cancer, venous thromboembolism, tumor-educated platelets, platelet RNA profiling, early diagnosis, screening
- Medical subject headings
- Neoplasms, Venous Thromboembolism, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to one year following venous thromboembolism
Secondary outcomes (10)
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.
Measured: Up to one year following venous thromboembolism
Recurrent venous thromboembolism
Adjudicated recurrent VTE (see full definition in protocol)
Measured: Up to one year following venous thromboembolism
Major bleeding
Adjudicated major bleeding according to the International Society on Thrombosis and Haemostasis criteria
Measured: Up to one year following venous thromboembolism
Clinically relevant non-major bleeding
Adjudicated clinically relevant non-major bleeding according to the International Society on Thrombosis and Haemostasis criteria
Measured: Up to one year following venous thromboembolism
Composite of major bleeding and clinically relevant non-major bleeding
Measured: Up to one year following venous thromboembolism
All-cause mortality
Measured: Up to one year following venous thromboembolism
Cancer-related mortality
Measured: Up to one year following venous thromboembolism
Solid cancer
Measured: Up to one year following venous thromboembolism
Hematological cancer
Measured: Up to one year following venous thromboembolism
Composite of solid cancer and lymphoma
Measured: Up to one year following venous thromboembolism
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2016 (estimated)
- Study startJun 2016
- Primary completionOct 2020
- Study completionOct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 476 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Harry R. Buller, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Harry Büller, MD, PhD, Study chair, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02739867
- Sponsor's protocol ID
- PLATO-VTE
- Status last verified
- Feb 2022
- First submitted
- 12 Apr 2016
- Last updated
- 16 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 26525104
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Platelet RNA Profiling to Detect Occult Cancer in Patients With Unprovoked Venous Thromboembolism
- ClinicalTrials.gov ID
- NCT02739867
- Acronym / sponsor ID
- PLATO-VTE
- Conditions
- Neoplasms, Venous Thromboembolism
- Keywords
- occult cancer, venous thromboembolism, tumor-educated platelets, platelet RNA profiling, early diagnosis, screening
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 476 participants (actual)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Study start
- Jun 2016
- Primary completion
- Oct 2020 (actual)
- Study completion
- Oct 2021 (actual)
- First posted
- 15 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
10 secondary outcomes
Early-stage solid cancer
Time frame: Up to one year following venous thromboembolism
Recurrent venous thromboembolism
Time frame: Up to one year following venous thromboembolism
Major bleeding
Time frame: Up to one year following venous thromboembolism
Clinically relevant non-major bleeding
Time frame: Up to one year following venous thromboembolism
Composite of major bleeding and clinically relevant non-major bleeding
Time frame: Up to one year following venous thromboembolism
All-cause mortality
Time frame: Up to one year following venous thromboembolism
Cancer-related mortality
Time frame: Up to one year following venous thromboembolism
Solid cancer
Time frame: Up to one year following venous thromboembolism
Hematological cancer
Time frame: Up to one year following venous thromboembolism
Composite of solid cancer and lymphoma
Time frame: Up to one year following venous thromboembolism
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2022.
- Background: PubMed 26525104Best 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Harry Büller, MD, PhD study chair
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
14 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neoplasms and Venous Thromboembolism, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 14 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Netherlands, Italy, Belgium, Canada, Germany and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Any solid or hematological cancer (time frame: Up to one year following venous thromboembolism). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02739867, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2022.