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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.
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.
The 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.
The result is a pattern, not a diagnosis, and the commonest harm this test does is being read as one.
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.
Written only from the label or guideline text cited on this page. Not medical advice; your own report and the reading your team gives it come first.
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.
“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.”
van Dongen et al., Leukemia 2003No approval uses this readout as a threshold. It is defined by van Dongen et al., Leukemia 2003: BIOMED-2 multiplex PCR for clonal immunoglobulin and T-cell receptor rearrangements.
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