ArticleThe Journal of molecular diagnostics : JMD2019
Establishment of Immunoglobulin Heavy (IGH) Chain Clonality Testing by Next-Generation Sequencing for Routine Characterization of B-Cell and Plasma Cell Neoplasms.
Article in The Journal of molecular diagnostics : JMD, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 52 papers.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
52 citing papers in PubMed, 83 citations in OpenAlex.
- Trial
- Sequential lymphoid neoplasms mimicking relapse of mediastinal grey zone lymphoma in a patient with germline variants in EP300 and PTPRK.Virchows Archiv : an international journal of pathology · 2026Article
- TCR γδ cell-specific STAT5 gain of function induces a druggable chronic human immune dysregulation.Journal of human immunity · 2026Article
- Comparative Analysis Between the EuroClonality-NGS Approach and the LymphoTrackInternational journal of molecular sciences · 2026Article
- Low flow cytometry events in detecting CNS involvement in pediatric B-cell precursor ALL: NGS validation and prognostic significance.Blood advances · 2026Article
- Comparative evaluation of two NGS-based assays for somatic hypermutation analysis of IGHV genes in chronic lymphocytic leukemia.Blood research · 2026Article
- Indolent primary cutaneous B-cell lymphomas resemble persistent antigen reactions without signs of dedifferentiation.Nature communications · 2026Article
- Validation of an Adapted NGS-Based Clonality Assay for MRD Monitoring in B-ALL Using Archived and Follow-Up Samples.EJHaem · 2025Article
- Molecular measurable residual disease by immunoglobulin gene rearrangements on circulating tumor DNA predicts outcome in diffuse large B-cell lymphoma.Haematologica · 2025Article
- Prognostic relevance of immunoglobulin heavy chain rearrangement and immunoglobulin kappa light chain rearrangement in patients with diffuse large B cell lymphoma.The oncologist · 2025Article
- [Chinese expert consensus on minimal residual disease detection in multiple myeloma based on bone marrow samples (2024)].Zhonghua xue ye xue za zhi = Zhonghua xueyexue zazhi · 2024Article
- Molecular Features of HHV8 Monoclonal Microlymphoma Associated with Kaposi Sarcoma and Multicentric Castleman Disease in an HIV-Negative Patient.International journal of molecular sciences · 2024Article
- Evaluation of next-generation sequencing versus next-generation flow cytometry for minimal-residual-disease detection in Chinese patients with multiple myeloma.Discover oncology · 2024Article
- Assessment of Bone Marrow Involvement in B-Cell non-Hodgkin Lymphoma Using Immunoglobulin Gene Rearrangement Analysis with Next-Generation Sequencing.Journal of clinical laboratory analysis · 2024Article
- Quantification of Measurable Residual Disease Detection by Next-Generation Sequencing-Based Clonality Testing in B-Cell and Plasma Cell Neoplasms.The Journal of molecular diagnostics : JMD · 2024Article
- [Minimal residual disease assessment and progress in multiple myeloma].Zhonghua xue ye xue za zhi = Zhonghua xueyexue zazhi · 2024Article
- Diagnostic and prognostic molecular pathology of lymphoid malignancies.Virchows Archiv : an international journal of pathology · 2024Review
- Minimal residual disease detection by next-generation sequencing of different immunoglobulin gene rearrangements in pediatric B-ALL.Nature communications · 2023Article
- Article
- Prospective evaluation of minimal residual disease in the phase II FORTE trial: a head-to-head comparison between multiparameter flow cytometry and next-generation sequencing.EClinicalMedicine · 2023Article
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Authors and funding
18 authors at 1 institution in 1 country.
Funding
Abstract
Immunoglobulin heavy chain (IGH) clonality testing by next-generation sequencing (NGS) offers unique advantages over current low-throughput methods in the assessment of B-cell lineage neoplasms. Clinical use remains limited because assays are not standardized and validation/implementation guidelines are not yet developed. Herein, we describe our clinical validation and implementation of NGS IGH clonality testing and summarize our experience based on extensive routine use. NGS-based clonality testing targeting IGH FR1, FR2, FR3, and the conserved leader sequence upstream of FR1 was validated using commercially available kits. Data were analyzed by commercial and in-house-developed bioinformatics pipelines. Performance characteristics were evaluated directly comparing with capillary electrophoresis (CE) assays (BIOMED-2 primers). Assays were monitored after implementation (>1.5 years), concurrently testing by CE methods. A total of 1189 clinical samples were studied (94 validation, 1095 postimplementation). NGS showed superior performance compared with CE assays. For initial assessment, clonality detection rate was >97% for all malignancy types. Concordance with CE was 96%; discordances were related to higher sensitivity/resolution of NGS and improved detection in cases with high somatic hypermutation. Routine NGS clonality assessment is feasible and superior to existing assays, enabling accurate and specific index clone assessment and future tracking of all rearrangements in a patient sample. Successful implementation requires new standardization, validation, and implementation processes, which should be performed as a multicenter and multidisciplinary collaboration.
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Registered trials
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