Clinical implication of minimal residual disease assessment by next-generation sequencing-based immunoglobulin clonality assay in pediatric B-acute lymphoblastic leukemia

Lee, Jae Woo; Kim, Yonggoo; Ahn, Ari; Lee, Jong-Mi; Yoo, Jae Won; Kim, Seongkoo; Cho, Bin; Chung, Nack‐Gyun; Kim, Myungshin

doi:10.3389/fonc.2022.957743

Cited by 5 publications

(5 citation statements)

References 15 publications

(19 reference statements)

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“…Interestingly, three cases detected with positive MRD using the CD45-ROR1 panel were detected to be MRD-negative on using the ERIC eight-color panel. To validate the MRD results of two of the three samples, NGS, which is a highly sensitive method (Lee et al, 2022), was used. The results showed that both were MRD-positive.…”

Section: Discussionmentioning

confidence: 99%

Performance of a novel eight‐color flow cytometry panel for measurable residual disease assessment of chronic lymphocytic leukemia

Chen,

Zhao

et al. 2024

Cytometry Part B Clinical

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BackgroundMeasurable residual disease (MRD) is an important prognostic indicator of chronic lymphocytic leukemia (CLL). Different flow cytometric panels have been developed for the MRD assessment of CLL in Western countries; however, the application of these panels in China remains largely unexplored.MethodsOwing to the requirements for high accuracy, reproducibility, and comparability of MRD assessment in China, we investigated the performance of a flow cytometric approach (CD45‐ROR1 panel) to assess MRD in patients with CLL. The European Research Initiative on CLL (ERIC) eight‐color panel was used as the “gold standard.”ResultsThe sensitivity, specificity, and concordance rate of the CD45‐ROR1 panel in the MRD assessment of CLL were 100% (87/87), 88.5% (23/26), and 97.3% (110/113), respectively. Two of the three inconsistent samples were further verified using next‐generation sequencing. In addition, the MRD results obtained from the CD45‐ROR1 panel were positively associated with the ERIC eight‐color panel results for MRD assessment (R = 0.98, p < 0.0001). MRD detection at low levels (≤1.0%) demonstrated a smaller difference between the two methods (bias, −0.11; 95% CI, −0.90 to 0.68) than that at high levels (>1%). In the reproducibility assessment, the bias was smaller at three data points (within 24, 48, and 72 h) in the CD45‐ROR1 panel than in the ERIC eight‐color panel. Moreover, MRD levels detected using the CD45‐ROR1 panel for the same samples from different laboratories showed a strong statistical correlation (R = 0.99, p < 0.0001) with trivial interlaboratory variation (bias, 0.135; 95% CI, −0.439 to 0.709). In addition, the positivity rate of MRD in the bone marrow samples was higher than that in the peripheral blood samples.ConclusionsCollectively, this study demonstrated that the CD45‐ROR1 panel is a reliable method for MRD assessment of CLL with high sensitivity, reproducibility, and reliability.

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Section: Discussionmentioning

confidence: 99%

Performance of a novel eight‐color flow cytometry panel for measurable residual disease assessment of chronic lymphocytic leukemia

Chen,

Zhao

et al. 2024

Cytometry Part B Clinical

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“…Interestingly, 3 cases presented positive MRD as detected by CD45-ROR1 panel while negative MRD detected by ERIC 8-color panel. In order to validate the MRD results, NGS, a highly sensitive method (32), was used to assess the MRD status of 2 of the 3 samples, and the results showed that both of them were MRD positive. This result further veri ed the reliability and higher sensitivity of CD45-ROR1 panel in the MRD monitoring of CLL.…”

Section: Discussionmentioning

confidence: 99%

Performance of a novel 8-color flow cytometry panel in the detection of minimal residual disease assessment of chronic lymphocytic leukemia

Chen

Zhao

et al. 2022

Preprint

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Background The status of minimal residual disease (MRD) has been established as an important prognostic indicator in chronic lymphocytic leukemia (CLL). Methods Owing to the requirements of high accuracy, reproducibility and comparability of MRD, this study investigated the performance of a flow cytometric approach (CD45-ROR1 panel) in the MRD detection of CLL patients, with European Research Initiative on CLL (ERIC) 8-color panel as the “gold standard”. Results The sensitivity, specificity and concordance rate of CD45-ROR1 panel in the MRD assessment of CLL were 100% (87/87), 88.5% (23/26) and 97.3% (110/113), respectively. Two of the 3 non-consistent samples were further verified by the next-generation sequencing. In addition, the MRD results obtained from the CD45-ROR1 panel were positively associated with the ERIC 8-color results for MRD assessment (R = 0.98, p < 0.0001). MRD detection at low levels (≤ 1.0%) demonstrated a smaller difference between the two methods (bias, -0.11; 95% CI, -0.90-0.68) as compared with that at high levels (>0.1%). For the reproducibility assessment, the bias was smaller at three datapoints in the CD45-ROR1 panel as compared with that of the ERIC 8-color panel. Moreover, MRD level detected using the CD45-ROR1 panel for the same samples between different laboratories showed a strong statistical correlation (R = 0.99, p < 0.0001) with a trivial inter-laboratory variation (bias, 0.135; 95% CI, -0.439-0.709). Interesingly, the MRD level detected in the lymph nodes samples were significantly higher than that of the peripheral blood and bone marrow samples (p = 0.029). Conclusions Collectively, this study demonstrates that the CD45-ROR1 panel is a reliable method for the MRD assessment of CLL, with higher sensitivity, reproducibility, and reliability.

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“…NGS offers higher sensitivity and specificity than multiple PCR, making high‐resolution examinations of all rearrangement events in a sample possible. Ig clonality analysis using NGS has proven to be a sensitive tool for detecting clonality and minimal residual disease (MRD) in various lymphoid hematologic neoplasm [ 20 , 21 , 22 , 23 ]. Although NGS‐based Ig testing for clonality detection and MRD monitoring has been previously studied, to the best of our knowledge, its clinical implications and use in BMI assessment have not been described.…”

Section: Introductionmentioning

confidence: 99%

Assessment of Bone Marrow Involvement in B‐Cell non‐Hodgkin Lymphoma Using Immunoglobulin Gene Rearrangement Analysis with Next‐Generation Sequencing

Jeon,

Yu,

Kim

et al. 2024

Clinical Laboratory Analysis

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BackgroundAssessment of bone marrow involvement (BMI) in non‐Hodgkin lymphoma (NHL) is crucial for determining patient prognosis and treatment strategy. We assessed the prognostic value of next‐generation sequencing (NGS)–based immunoglobulin (Ig) gene clonality analysis as an ancillary test for BMI evaluation in NHL.MethodsA retrospective cohort of 124 patients newly diagnosed with B‐cell NHL between 2019 and 2022 was included. NGS‐based Ig clonality analysis was conducted using LymphoTrak IGH FR1 Assay and IGK Assay (Invivoscribe Technologies, San Diego, CA, USA) on BM aspirate samples, and the results were compared with those of histopathological BMI (hBMI).ResultsAmong the 124 patients, hBMI was detected in 16.9% (n = 21). The overall agreement of BMI between Ig clonality analyses and histopathological analysis for IGH, IGK, and either IGH or IGK was 86.3%, 92.7%, and 90.3%. The highest positive percent agreement was observed with clonal rearrangements of either IGH or IGK gene (90.5%), while the highest negative percent agreement was observed with clonal rearrangement of IGK gene (96.1%). For the prediction of hBMI, positive prediction value ranged between 59.1% and 80.0% and the negative prediction value ranged between 91.3% and 97.9%.ConclusionNGS‐based clonality analysis is an analytic platform with a substantial overall agreement with histopathological analysis. Assessment of both IGH and IGK genes for the clonal rearrangement analysis could be considered for the optimal diagnostic performance of BMI detection in B‐cell NHL.

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Clinical implication of minimal residual disease assessment by next-generation sequencing-based immunoglobulin clonality assay in pediatric B-acute lymphoblastic leukemia

Cited by 5 publications

References 15 publications

Performance of a novel eight‐color flow cytometry panel for measurable residual disease assessment of chronic lymphocytic leukemia

Performance of a novel eight‐color flow cytometry panel for measurable residual disease assessment of chronic lymphocytic leukemia

Performance of a novel 8-color flow cytometry panel in the detection of minimal residual disease assessment of chronic lymphocytic leukemia

Assessment of Bone Marrow Involvement in B‐Cell non‐Hodgkin Lymphoma Using Immunoglobulin Gene Rearrangement Analysis with Next‐Generation Sequencing

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