Clinical trial · Observational
LEF1 EXPRESSION IN B-CELL CHRONIC LYMPHOCYTIC LEUKEMIA PATIENTS: A MARKER FOR DIAGNOSIS AND SURVIVAL PREDICTION
RILEVANZA DIAGNOSTICA DELLA ESPRESSIONE DI LEF-1 NEL LINFOMA A PICCOLI LINFOCITI/LEUCEMIA LINFATICA CRONICA B
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Lymphocytic Leukemia (CLL) / Small Lymphocytic Lymphoma (SLL) | Small Lymphocytic Lymphoma | ALIAS | 0.85 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- LEF1 expression
- timeFrame
- From the beginning of the study to the analysis of all the results: 24 months
- description
- To evaluate the expression of the LEF-1 molecule at diagnosis, in a cohort of patients with a clinical and histopathological diagnosis of SLL/CLL, with an expected value of around 70% of positive cases.
Secondary outcomes (2)
- measure
- Relationship
- timeFrame
- From the beginning of the study to the analysis of all the results: 24 months
- description
- To evaluate the relationship between immunohistochemical and mutational parameters collected at diagnosis and clinical data.
- measure
- New markers
- timeFrame
- From the beginning of the study to the analysis of all the results: 24 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Criteria: * \- 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
References
Publications (0)
Data not yet available