Actively Recruiting
Testing the Diagnostic Supremacy of Sequencing-only Approaches in Hematologic Malignancies: an Observational Trial
Led by Munich Leukemia Laboratory · Updated on 2024-12-17
100
Participants Needed
1
Research Sites
56 weeks
Total Duration
On this page
Sponsors
M
Munich Leukemia Laboratory
Lead Sponsor
I
Illumina, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating how new sequencing methods like whole genome sequencing (WGS) and whole transcriptome sequencing (WTS) can improve the diagnosis of blood cancers and related diseases. Current routine diagnostic methods rely on five main techniques and can diagnose 90% of cases, but 10% remain unclear. This study aims to see if WGS and WTS can provide more accurate diagnoses for these challenging cases, helping guide better patient care. The study observes patients who have unclear diagnoses after standard testing. Researchers will compare the diagnostic results from WGS and WTS alone to those from traditional gold standard methods. They will use a large reference collection of over 5,500 cases and an algorithm to match new patient profiles to similar known cases. The process for sequencing takes about 5 to 7 days, similar to current methods, and the study will follow patients for up to nine months after enrollment. Participants will provide samples containing at least 20% tumor cells from bone marrow or blood. Throughout the study, researchers will analyze sequencing data and compare it to standard diagnoses. They will also measure the time taken for diagnosis, actionable treatment targets, disease stage, and costs. The main outcome is determining if sequencing-only approaches can deliver better diagnoses, with assessments made at diagnosis and followed for about one year.
CONDITIONS
Brief Title
Solving Riddles Through Sequencing
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients investigated for a suspected hematological disorder
- Unclear diagnosis after routine internal diagnosis
- Unusual clinical course or refractory/non-responder status
- Multiple parallel hematological conditions
- Difficult, rare, therapy-associated, or secondary neoplasms
- Unsatisfactory current diagnostic workup in accuracy or clinical behavior
- At least 18 years old
- Sample with minimum 20% tumor content in bone marrow or peripheral blood
- Provided informed consent
You will not qualify if you...
- Sample not suitable for advanced diagnosis or fails quality control
- Sample uses wrong anticoagulant or has freeze-thaw or heat damage
- Sample material too scarce for routine gold-standard diagnosis (tumor content less than 20%)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 14 days
Participants undergo advanced sequencing tests to compare sequencing-only approaches to classical diagnostic methods for hematologic malignancies.
1 to 2 visits depending on sample processing
Duration - Up to 9 months
Participants are observed for up to 9 months to assess clinical outcomes and diagnostic accuracy after sequencing-based evaluation.
Periodic visits over 9 months depending on clinical course
Trial Site Locations
Total: 1 location
1
MLL Munich Leukemia Laboratory
Munich, Germany
Actively Recruiting
Research Team
T
Torsten Haferlach, MD
A
Adam Wahida, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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