Mucorales PCR Screening in At-risk Hematology Patients

NCT ID: NCT05925660

Last Updated: 2023-12-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-06
• Study Completion Date: 2024-06-30

Brief Summary

Patients with leukemia are treated with intensive chemotherapy and often have to undergo a stem cell transplantation which makes their immune system extremely vulnerable. This puts them at risk for invasive fungal infections, of which invasive mucormycosis (IM) is one of the most dangerous ones. Treatment of IM is complex and mortality rates are still extremely high, ranging from 40% to 80% and sometimes even higher if the central nervous system is involved. Mucormycosis requires immediate intervention due to the rapidly progressive and destructive nature of the infection. But the diagnosis is often made too late…

Better survival can be achieved with a faster diagnosis. A new test has recently been developed for detection of Mucorales DNA by PCR. The polymerase chain reaction (PCR) is a method that allows to quickly make millions of copies of, for example, Mucorales DNA in order to detect it in the blood at an early stage. Because blood can easily be obtained, without an additional burden on the patient, the test could be interesting for screening for these infections, which then offers the opportunity to start an adequate treatment more quickly.

However, the test is now only performed if there is a clinical suspicion of IM. But at that point, precious time has already been lost, and often the patient can no longer be cured. In this study the utility of the Mucorales PCR as a possible screening test in at-risk patients is assessed. The participants, hospitalised patients with leukemia, will be screened twice weekly with a Mucorales PCR test during their most vulnerable period. If the study shows that the test helps in diagnosing IM faster, this could have an important impact on the treatment and survival of these at-risk patients.

Conditions

Mucormycosis

Keywords

Invasive Mycosis; Neutropenia; Leukemia; Stem Cell Transplant Complications; Invasive Mucormycosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Interventions

Mucorales PCR (MucorGenius, PathoNostics, Maastricht, The Netherlands)

Mucorales PCR screening twice weekly during hospitalisation

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Underlying disease:

• Start of remission induction chemotherapy for acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) that is newly diagnosed or in first relapse after hematological remission lasting for a minimum duration of 6 months; OR
• Start of myeloablative conditioning regimen to prepare for a first allogeneic hematopoietic cell transplantation (HCT).
• Expected prolonged neutropenia (ANC< 0.5 x 109 /L for ≥ 7 days).
• Planned hospital admission for the duration of the neutropenic phase.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AZ Sint-Jan AV

OTHER

Sponsor Role: collaborator

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University Hospitals Leuven

Leuven, Vlaams-Brabant, Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Robina Aerts, MD

Role: CONTACT

Phone: +32 16 34 48 77

Email: robina.aerts@kuleuven.be

Johan Maertens, MD, PhD

Role: CONTACT

Phone: +32 16 34 66 70

Email: johan.maertens@uzleuven.be

Facility Contacts

Robina Aerts, MD

Role: primary

Yuri Vanbiervliet, MD

Role: backup

Other Identifiers

IN-EU-131-6808

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

S-number CTC UZ Leuven

Identifier Type: OTHER

Identifier Source: secondary_id

S67347

Identifier Type: -

Identifier Source: org_study_id