{"entity":{"id":"ig-tcr-clonality","kind":"biomarker","name":"Immunoglobulin and T-cell receptor clonality","aka":["IGH clonality","TCR clonality","clonal rearrangement","gene rearrangement study","B-cell clonality","T-cell clonality","BIOMED-2"],"tldr":"A test that asks whether a group of lymphocytes all descend from one cell. Cancer is one family; a normal immune response is a crowd. It is used when the appearance under the microscope does not settle the question.","summary":"Every lymphocyte rearranges its antigen receptor genes into a sequence unique to itself, so a lymphoma made of one clone gives amplicons of one length and sequence while a reactive population gives a smooth spread.\n\nThe European BIOMED-2 collaboration standardised the assay into 107 primers in 18 multiplex tubes covering IGH in two configurations, IGK, IGL, TCRB, TCRG and TCRD plus the BCL1-IGH and BCL2-IGH translocations, with products read by heteroduplex analysis or fragment sizing. The complementarity of the tubes is what makes the detection rate high: combined IGH and IGK tubes detect virtually all clonal B-cell proliferations even where somatic hypermutation is heavy, and combined TCRB and TCRG tubes detect virtually all clonal T-cell populations (van Dongen 2003). The EuroClonality-NGS successor sequences the amplicons rather than sizing them and produces a patient-specific sequence that can be followed afterwards as a residual disease marker.\n\nThe result is a pattern, not a diagnosis, and the commonest harm this test does is being read as one.","asOf":"2026-09-30","links":[{"label":"van Dongen et al., Leukemia 2003: BIOMED-2 multiplex PCR for clonal immunoglobulin and T-cell receptor rearrangements","url":"https://doi.org/10.1038/sj.leu.2403202"}],"tags":["biomarker","lymphoma"],"related":[],"cancers":["non-hodgkin-lymphoma","cutaneous-t-cell-lymphoma","sezary-syndrome","malt-lymphoma","peripheral-t-cell-lymphoma","follicular-lymphoma"],"sections":[],"technologies":["clonality-testing","ngs-mrd-clonoseq","flow-cytometry-mrd"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":["clonal-evolution"],"terms":["ngs","mrd","lymphoma-bio-germinal-centre"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"noParentReason":"The readout is a pattern across the immunoglobulin and T-cell receptor loci rather than a result for one gene or protein: the question is whether the population is monoclonal, and no single parent gene answers it.","measurement":"sequencing-variant","scoringRule":{"text":"Multiplex PCR, or targeted sequencing, across the V, D and J segments, reported as clonal, polyclonal or oligoclonal, with the loci tested named. A clonal result should be read with the morphology and immunophenotype and never alone: clonal populations occur in reactive, autoimmune and age-related conditions, and a polyclonal result does not exclude a lymphoma in which the malignant cells are a small minority.","quote":"In particular, combined application of IGH (VH-JH and DH-JH) and IGK tubes can detect virtually all clonal B-cell proliferations, even in B-cell malignancies with high levels of somatic mutations.","source":"https://doi.org/10.1038/sj.leu.2403202","sourceLabel":"van Dongen et al., Leukemia 2003"},"thresholds":[],"definedBy":{"label":"van Dongen et al., Leukemia 2003: BIOMED-2 multiplex PCR for clonal immunoglobulin and T-cell receptor rearrangements","url":"https://doi.org/10.1038/sj.leu.2403202"},"tests":[],"assays":[],"companionDiagnostics":[],"forPatient":"A clonal result is a piece of evidence, not a verdict. It is most useful when a biopsy is small or the appearance is borderline, and it is read together with everything else. A report that says clonal does not by itself mean cancer."},"route":"/biomarkers/ig-tcr-clonality/","neighbours":{"cancer":[{"id":"cutaneous-t-cell-lymphoma","kind":"cancer","name":"Cutaneous T-cell lymphoma (mycosis fungoides and Sezary syndrome)","route":"/cancers/cutaneous-t-cell-lymphoma/"},{"id":"dlbcl","kind":"cancer","name":"Diffuse large B-cell lymphoma","route":"/cancers/dlbcl/"},{"id":"malt-lymphoma","kind":"cancer","name":"Extranodal marginal zone lymphoma of mucosa-associated lymphoid tissue (MALT lymphoma)","route":"/cancers/malt-lymphoma/"},{"id":"follicular-lymphoma","kind":"cancer","name":"Follicular lymphoma","route":"/cancers/follicular-lymphoma/"},{"id":"marginal-zone-lymphoma","kind":"cancer","name":"Marginal zone lymphoma","route":"/cancers/marginal-zone-lymphoma/"},{"id":"angioimmunoblastic-t-cell-lymphoma","kind":"cancer","name":"Nodal T-follicular helper cell lymphoma, angioimmunoblastic type (angioimmunoblastic T-cell lymphoma)","route":"/cancers/angioimmunoblastic-t-cell-lymphoma/"},{"id":"non-hodgkin-lymphoma","kind":"cancer","name":"Non-Hodgkin lymphoma (all types)","route":"/cancers/non-hodgkin-lymphoma/"},{"id":"peripheral-t-cell-lymphoma","kind":"cancer","name":"Peripheral T-cell lymphomas (including cutaneous T-cell lymphoma)","route":"/cancers/peripheral-t-cell-lymphoma/"},{"id":"richter-transformation-cll","kind":"cancer","name":"Richter transformation of chronic lymphocytic leukaemia","route":"/cancers/richter-transformation-cll/"},{"id":"sezary-syndrome","kind":"cancer","name":"Sezary syndrome","route":"/cancers/sezary-syndrome/"}],"technology":[{"id":"clonality-testing","kind":"technology","name":"Immunoglobulin and T-cell receptor clonality testing","route":"/technologies/clonality-testing/"},{"id":"flow-cytometry-mrd","kind":"technology","name":"Multiparameter flow cytometry MRD","route":"/technologies/flow-cytometry-mrd/"},{"id":"ngs-mrd-clonoseq","kind":"technology","name":"NGS-based MRD (clonoSEQ and molecular MRD)","route":"/technologies/ngs-mrd-clonoseq/"}],"pathway":[{"id":"clonal-evolution","kind":"pathway","name":"Clonal evolution & minimal residual disease","route":"/pathways/clonal-evolution/"}],"term":[{"id":"mrd","kind":"term","name":"Minimal / molecular residual disease (MRD)","route":"/terms/mrd/"},{"id":"ngs","kind":"term","name":"Next-generation sequencing (NGS)","route":"/terms/ngs/"},{"id":"lymphoma-bio-germinal-centre","kind":"term","name":"The germinal centre: why lymphoma starts where antibodies are made","route":"/terms/lymphoma-bio-germinal-centre/"}]}}