LEF1 EXPRESSION IN B-CELL CHRONIC LYMPHOCYTIC LEUKEMIA PATIENTS: A MARKER FOR DIAGNOSIS AND SURVIVAL PREDICTION
Recruiting now
Conditions studied: Chronic Lymphocytic Leukemia (CLL) / Small Lymphocytic Lymphoma (SLL)
In brief
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
Key facts
- Study ID
- NCT07313982
- Run by
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
- People needed
- 350
- Starts
- 2025-12-31
- Expected to finish
- 2027-08-31
- Last updated by the study team
- 2026-01-02
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- - 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
Where it is running
- Irccs Azienda Ospedaliero-Universitaria Di Bologna — Bologna, BOLOGNA, Italy (enrolling)
Full record on ClinicalTrials.gov
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