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New algorithm could spare cancer patients unnecessary CT scans for blood clots

NCT ID NCT04657120

Diagnosis Sponsor: Leiden University Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether a simple checklist and blood test (the YEARS algorithm) can safely rule out pulmonary embolism (a blood clot in the lungs) in people with active cancer, compared to the standard approach of doing a CT scan on everyone. About 700 cancer patients with suspected clots were randomly assigned to either the YEARS method or a CT scan. The goal was to see if the algorithm could reduce the number of CT scans without missing dangerous clots.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
YEARS algorithm (a clinical decision rule using symptoms and D-dimer blood test)
What this could lead to
If successful, this could provide a safer, faster way to diagnose or rule out blood clots in the lungs for cancer patients, reducing unnecessary radiation from CT scans.
What could go wrong
This is a completed study, but the algorithm may not be as accurate in all cancer types or settings. There is a small risk of missing a clot, which could be serious.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

698 people

The number who actually took part.

Started

Jun 2019

Finished

Aug 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: * Clinically suspected PE as judged by the treating clinician * Any type of active malignancy (other than basal-cell or squamous-cell carcinoma of the skin), defined as diagnosis within six months before the study inclusion (as confirmed histologically or high suspicion as judged by the clinician), receiving treatment for malignancy at time of inclusion or during 6 months prior to randomization, including recurrent or local metastatic malignancy * Outpatients and hospitalized patients * Age ≥ 18 years * Signed and dated informed consent, available for start of the trial procedure Exclusion Criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: * Medical or psychological condition that would not permit completion of the study or signing of informed consent, including life expectancy less than 3 months, or unwillingness to sign informed consent * Treatment with full-dose therapeutically dosed anticoagulation that was initiated 24 hours or more prior to eligibility assessment * Contraindication to CTPA * contrast allergy Hemodynamic instability at presentation (as a consequence of concurrent acute PE or otherwise), indicated by at least one of the following: * systolic blood pressure (SBP) \< 100 mm Hg, or heart rate \>120 beats per minute or SBP drop by \> 40 mm Hg, for \> 15 min * need for catecholamines to maintain adequate organ perfusion and a systolic blood pressure of \> 100 mmHg * Need for cardiopulmonary resuscitation * Inability to follow-up * Life expectancy less than 3 months

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Conditions

The condition(s) this trial relates to.

cancer cardiovascular disorder disease Embolism Embolism and Thrombosis lung disorder neoplasm pulmonary embolism respiratory system disorder vascular disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cancer Cardiovascular diseases Diagnosis Embolism Embolism and thrombosis Lung diseases Pulmonary embolism Respiratory tract diseases Vascular diseases

Contacts and locations

Locations

  • Amphia Ziekenhuis

    Breda, Netherlands

  • Amsterdam UMC

    Amsterdam, Netherlands

  • Antwerpen University Hospital (UZA)

    Antwerp, Belgium

  • Bernhoven Ziekenhuis

    Uden, Netherlands

  • CHU Brest

    Brest, 29609, France

  • CHU Clermont-Ferrand

    Clermont-Ferrand, 63003, France

  • CHU Saint-Etienne

    Saint-Etienne, 42055, France

  • Centre Hospitalier Universitaire Vaudois (CHUV)

    Lausanne, Switzerland

  • Centre Hospitalier Universitaire de Liège (CHU Liège)

    Liège, Belgium

  • Cliniques Universitaires Saint-Luc (CUSL)

    Brussels, Belgium

  • Diakonessenhuis

    Utrecht, Netherlands

  • Flevoziekenhuis

    Almere Stad, Netherlands

  • Fondazione Policlinico Universitario A. Gemelli IRCCS

    Roma, Italy

  • Groene Hart Ziekenhuis

    Gouda, Netherlands

  • HEGP

    Paris, 75015, France

  • Haaglanden Medisch Centrum

    The Hague, Netherlands

  • Hospital Universitario Ramón y Cajal

    Madrid, Spain

  • Hôpital Louis Mourier - APHP

    Colombes, 92700, France

  • Hôpitaux Universitaires de Genève (HUG)

    Geneva, Switzerland

  • Jeroen Bosch Ziekenhuis

    's-Hertogenbosch, Netherlands

  • Leiden University Medical Center

    Leiden, Netherlands

  • Maasstad Ziekenhuis

    Rotterdam, Netherlands

  • Policlinico di Milano Ospedale Maggiore | Fondazione IRCCS Ca' Granda

    Milan, Italy

  • Radboud UMC

    Nijmegen, Netherlands

  • Reinier de Graaf Gasthuis

    Delft, Netherlands

  • Rijnstate Ziekenhuis

    Arnhem, Netherlands

  • Tergooi MC

    Hilversum, Netherlands

  • The Inselspital Bern

    Bern, Switzerland

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