Evaluating the YEARS algorithm for diagnosing pulmonary embolism in cancer patients

Safety and Efficiency of the YEARS Algorithm Versus Computed Tomography Pulmonary Angiography Alone for Suspected Pulmonary Embolism in Patients With Malignancy : HYDRA Study

This study is testing a new method called the YEARS algorithm to see if it can safely and effectively diagnose blood clots in the lungs for cancer patients, compared to the standard imaging test.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 1566 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University Hospital, Brest (other)
• Locations: 28 sites (Antwerpen and 27 other locations)
• Trial ID: NCT04657120 on ClinicalTrials.gov

What this trial studies

This study aims to validate the safety and efficiency of the YEARS algorithm for ruling out clinically suspected pulmonary embolism (PE) in patients with active malignancy, comparing it to the standard approach of computed tomography pulmonary angiography (CTPA). The YEARS algorithm has shown promise in previous studies, but its effectiveness in patients with malignancy, who may have altered diagnostic responses, needs further investigation. Participants will be randomly assigned to receive either the YEARS algorithm or CTPA for diagnosis. The goal is to improve patient care by potentially reducing unnecessary imaging procedures.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with clinically suspected pulmonary embolism and any type of active malignancy.

Not a fit: Patients with medical or psychological conditions that prevent them from completing the study or those with a life expectancy of less than three months may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could reduce the need for invasive imaging in cancer patients suspected of having pulmonary embolism.

How similar studies have performed: Previous studies have indicated that the YEARS algorithm is a safe and efficient diagnostic strategy, but its application in patients with malignancy is still being explored.

Eligibility criteria

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

Where this trial is running

Antwerpen and 27 other locations

• Antwerpen University Hospital (UZA) — Antwerpen, Belgium (RECRUITING)
• Cliniques Universitaires Saint-Luc (CUSL) — Bruxelles, Belgium (NOT_YET_RECRUITING)
• Centre Hospitalier Universitaire de Liège (CHU Liège) — Liège, Belgium (NOT_YET_RECRUITING)
• CHU Brest — Brest, France (RECRUITING)
• CHU Clermont-Ferrand — Clermont-Ferrand, France (NOT_YET_RECRUITING)
• Hôpital Louis Mourier - APHP — Colombes, France (NOT_YET_RECRUITING)
• HEGP — Paris, France (NOT_YET_RECRUITING)
• CHU Saint-Etienne — Saint-Étienne, France (RECRUITING)
• Policlinico di Milano Ospedale Maggiore | Fondazione IRCCS Ca' Granda — Milan, Italy (RECRUITING)
• Fondazione Policlinico Universitario A. Gemelli IRCCS — Roma, Italy (RECRUITING)
• Jeroen Bosch Ziekenhuis — 's-Hertogenbosch, Netherlands (ACTIVE_NOT_RECRUITING)
• Flevoziekenhuis — Almere, Netherlands (RECRUITING)
• Amsterdam UMC — Amsterdam, Netherlands (RECRUITING)
• Rijnstate Ziekenhuis — Arnhem, Netherlands (NOT_YET_RECRUITING)
• Amphia Ziekenhuis — Breda, Netherlands (RECRUITING)
• Reinier de Graaf Gasthuis — Delft, Netherlands (RECRUITING)
• Groene Hart Ziekenhuis — Gouda, Netherlands (RECRUITING)
• Tergooi MC — Hilversum, Netherlands (RECRUITING)
• Leiden University Medical Center — Leiden, Netherlands (RECRUITING)
• Radboud UMC — Nijmegen, Netherlands (RECRUITING)
• Maasstad Ziekenhuis — Rotterdam, Netherlands (RECRUITING)
• Haaglanden Medisch Centrum — The Hague, Netherlands (RECRUITING)
• Bernhoven Ziekenhuis — Uden, Netherlands (RECRUITING)
• Diakonessenhuis — Utrecht, Netherlands (RECRUITING)
• Hospital Universitario Ramón y Cajal — Madrid, Spain (RECRUITING)
• The Inselspital Bern — Bern, Switzerland (RECRUITING)
• Hôpitaux Universitaires de Genève (HUG) — Geneva, Switzerland (RECRUITING)
• Centre Hospitalier Universitaire Vaudois (CHUV) — Lausanne, Switzerland (RECRUITING)

Study contacts

• Principal investigator: Emily MARTENS, MD — Leiden University Medical Center
• Study coordinator: Emily MARTENS, MD

Conditions: Pulmonary Embolism, Embolism, Embolism and Thrombosis, Vascular Diseases, Cardiovascular Diseases, Lung Diseases, Respiratory Tract Diseases, Cancer