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Solving Riddles Through Sequencing

Study acronym: SIRIUS
StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 2 years later Aug 31, 2025 → Aug 31, 2027
See other at-risk trials from Munich Leukemia Laboratory

Record History

  1. Notable Primary completion pushed from Aug 31, 2025 to Aug 31, 2027 Completion pushed from Oct 1, 2026 to Oct 1, 2027 · Eligibility criteria expanded, about 12 words · Secondary endpoints: details revised at 3 of 4 entries · 1 more Show 4 more changesShow less
    • Completion pushed from Oct 1, 2026 to Oct 1, 2027
    • Eligibility criteria expanded, about 12 words
    • Secondary endpoints: details revised at 3 of 4 entries
    • Study description expanded, about 2 words
  2. Notable Primary completion date: Aug 31, 2023 to Aug 31, 2025v4
  3. Notable Primary completion date: Aug 31, 2022 to Aug 31, 2023v3
  4. Notable Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Oct 1, 2021 to Jan 19, 2022 · Study sites: 0 to 1v2 Show 2 more changesShow less
    • Start date changed from estimate of Oct 1, 2021 to Jan 19, 2022
    • Study sites: 0 to 1
  5. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 interdisciplinary teams in the context of specialized boards. With the advent of high throughput sequencing (mainly WGS and WTS) the possibility of a comprehensive and detailed portrait of the genetic alterations - specifically in challenging cases - has become a realistic alternative to classical methods. In SIRIUS the investigators will prospectively challenge this hypothesis to address the question of how often a better or final diagnosis can be delivered by WGS and/or WTS and if unclear cases can be efficiently resolved.
Trial Details
NCT Number NCT05046444
Lead Sponsor Munich Leukemia Laboratory
Collaborators: Illumina, Inc.
Conditions Leukemia, Hematologic Malignancy, Rare Diseases, Refractory Leukemia, Refractory Lymphoma, Unknown Primary Tumors
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov