Rapid Analysis of Infections by Spectrometry of Exhaled Breath
RAISE
Exhaled Breath Analysis for Rapid Diagnosis in Opportunistic Respiratory Infections in Hematological Patients
1 other identifier
observational
246
1 country
1
Brief Summary
To quantify the diagnostic, prognostic and therapeutic value of spectrometric analysis of exhaled breath from hematological patients with respiratory infection.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2019
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 15, 2017
CompletedFirst Posted
Study publicly available on registry
October 3, 2017
CompletedStudy Start
First participant enrolled
June 21, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2025
CompletedJuly 3, 2024
July 1, 2024
6 years
September 15, 2017
July 2, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Diagnostic accuracy
Accuracy (expressed as specificity/sensitivity/NPV/PPV) will be assessed as compared to the revised EORTC-MSG criteria, at moment of diagnosis by high-resolution CT and bronchoscopy
Through study completion (i.e. 6 weeks after diagnosis)
Secondary Outcomes (2)
Diagnostic accuracy at 2 weeks as compared to the revised EORTC-MSG response criteria using high-resolution CT
2 weeks after diagnosis
Diagnostic accuracy at 2 weeks as compared to the revised EORTC-MSG response criteria using high-resolution CT
6 weeks after diagnosis
Interventions
Spectrometric analysis of exhaled breath as screening for opportunistic respiratory infections
Eligibility Criteria
Patients at high risk for opportunistic respiratory infections due to acute myeloid or lymphatic leukemia (undergoing intensive treatment), patients who underwent allogeneic stem cell transplantation, and patients receiving autologous stem cell transplantation
You may qualify if:
- Age ≥ 18y at start of study
- One of the following diagnoses:
- De novo, refractory or relapsed AML/MDS receiving intensive chemotherapy
- De novo, refractory or relapsed ALL/T-lymphoblastic lymphoma receiving intensive chemotherapy
- Aplastic anemia requiring ATG therapy
- Any patient admitted for either autologous hematopoietic stem cell transplantation. Transplantation may not have been performed at time of enrolment.
- Any patient admitted with allogeneic hematopoietic stem cell transplantation within the last year, or planned during this admission.
- Written informed consent obtained from the patient
You may not qualify if:
- Signs of active respiratory infection
- If previously enrolled: incomplete clearance of all signs of respiratory infection (both clinically, microbiologically and radiologically).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospitals Leuven
Leuven, 3000, Belgium
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 15, 2017
First Posted
October 3, 2017
Study Start
June 21, 2019
Primary Completion
June 1, 2025
Study Completion
September 1, 2025
Last Updated
July 3, 2024
Record last verified: 2024-07
Data Sharing
- IPD Sharing
- Will not share