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Solving Riddles Through Sequencing

Recruitingn/aAges 18 Years - 99 YearsAllMunich Leukemia Laboratory
NCT05046444 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

During the last decades hematologists have excelled at improving and refining the classification, diagnosis, and thus ultimately the therapeutic decision-making process for their patients. This continuous evolution proceeded in parallel to seminal discoveries in basic science such as FISH, PCR and NGS. So far, the current WHO classification serves as reference to diagnostic decision making and is largely based on 5 diagnostic pillars: cytomorphology of peripheral blood and/or bone marrow smears, histology and immunohistochemistry of bone marrow trephine biopsies or lymph nodes, immunophenotyping, chromosome banding analysis supplemented by FISH analysis, molecular genetics including PCR and targeted panel sequencing via NGS. This leads to a swift diagnosis in 90 % of all cases. The leftover 10 % remain a challenge for hematopathologists and clinicians alike and are resolved through inter

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📋 Eligibility rules (as published)
Inclusion Criteria: * Patients having been investigated with a suspected hematological disorder and: * Having unclear diagnosis after internal routine diagnosis * Unusual clinical course * Unusual r/r status or non-responder * Multiple parallel hematological conditions * Difficult/rare therapy associated/secondary neoplasms * Current diagnostic workup is not satisfactory in terms of (1) accuracy (2) clinical behavior * Only samples of patients min. 18 years of age will be used * Material with a minimum of 20% tumor content in bone marrow or peripheral blood sample * Patient´s informed consent Exclusion Criteria: * Sample is not fit for state-of-the-art diagnosis, fails initial quality control. For quality insurance we will exclude samples with wrong anticoagulant sent. Samples with damage due to meteorological reasons (freeze-thaw damage or elevated temperature) will be excluded. * Samples with to scarce material jeopardizing routine gold-standard diagnosis will be excluded (tumor content \< 20 %).
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What it tests

  • Next Generation Sequencing
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Where

1 site
MLL Munich Leukemia Laboratory
Munich, Germany
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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