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Testing LEF1 protein levels to help diagnose chronic lymphocytic leukemia

Looks at LEF1 levels in adults with chronic lymphocytic leukemia.

Plain-language title generated from the registry record
Registry title: LEF1 EXPRESSION IN B-CELL CHRONIC LYMPHOCYTIC LEUKEMIA PATIENTS: A MARKER FOR DIAGNOSIS AND SURVIVAL PREDICTION

Key facts

Where
Bologna, ItalySee the site

Where in Italy

  • IRCCS Azienda Ospedaliero-Universitaria di BolognaBologna, ItalyTaking people

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Trial details

Who runs it
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Trial code
NCT07313982
Record updated
2 January 2026
Original description
Chronic lymphocytic leukemia (CLL) is a highly heterogeneous B-cell hematological malignancy characterized by clonal expansion and accumulation of morphologically mature B-lymphocytes with a peculiar immunophenotype in peripheral blood, bone marrow, and secondary lymphoid tissues. Diagnosis is usually possible by flow cytometry, while lymph node and/or bone marrow biopsy may be helpful if immunophenotyping is inconclusive. A better understanding of pathogenesis has, recently, allowed the identification of new markers, improving patient stratification, implementing the therapeutic armamentarium with new agents targeting key intracellular signaling pathways. The canonical Wnt/β-catenin pathway is well recognized and known to drive malignant transformation of several cancer types including B-CLL. High expression of WNT3 and its transcription factor LEF1 in CLL considered as one of the strongest facts supporting the role of this pathway in CLL.Read full original descriptionShow less

RILEVANZA DIAGNOSTICA DELLA ESPRESSIONE DI LEF-1 NEL LINFOMA A PICCOLI LINFOCITI/LEUCEMIA LINFATICA CRONICA B

Chronic lymphocytic leukemia (CLL) is a highly heterogeneous B-cell hematological malignancy characterized by clonal expansion and accumulation of morphologically mature B-lymphocytes with a peculiar immunophenotype in peripheral blood, bone marrow, and secondary lymphoid tissues. Diagnosis is usually possible by flow cytometry, while lymph node and/or bone marrow biopsy may be helpful if immunophenotyping is inconclusive. A better understanding of pathogenesis has, recently, allowed the identification of new markers, improving patient stratification, implementing the therapeutic armamentarium with new agents targeting key intracellular signaling pathways. The canonical Wnt/β-catenin pathway is well recognized and known to drive malignant transformation of several cancer types including B-CLL. High expression of WNT3 and its transcription factor LEF1 in CLL considered as one of the strongest facts supporting the role of this pathway in CLL.

The evaluation of LEF-1 expression by immunohistochemistry in the diagnostic setting is still limited and a substantial number of CLL patients with negative LEF-1 expression has been reported. This is a study of LEF-1 expression to test the utility of using it for optimizing the B-CLL diagnosis and correlate it with the immunohistochemical, clinical and molecular data and compare LEF-1 negative and positive cases to identify a possible LEF-1 expression related signature that could be useful in differential diagnosis, in prognostic stratification and possibility of using targeted drugs

Inclusion: Patients with a confirmed diagnosis of SLL/CLL - B; Males and females, adults at diagnosis; Patients with available tissue (lymph node, extralymph node, or bone marrow) on which immunohistochemical analysis including LEF-1 has been performed and who have already submitted mutational and/or cytogenetic analysis data.

Exclusion: - Patients with LEF1-positive indolent B-cell lymphomas not supported by a genetic evaluation with SSL/CLL; CLL cases for which a biopsy is not available.

ClinicalTrials.gov NCT07313982