LEF1 EXPRESSION IN B-CELL CHRONIC LYMPHOCYTIC LEUKEMIA PATIENTS: A MARKER FOR DIAGNOSIS AND SURVIVAL PREDICTION

NCT07313982 | Recruiting

• 1 other identifier: LLC/LEF1 2024
• Study Type: observational
• Target: 350
• Locations: 1 country
• Sites: 1

Brief Summary

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

Chronic Lymphocytic Leukemia (CLL) / Small Lymphocytic Lymphoma (SLL)

Outcome Measures

Primary Outcomes (1)

• LEF1 expression

  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.

  From the beginning of the study to the analysis of all the results: 24 months

Secondary Outcomes (2)

• Relationship

  From the beginning of the study to the analysis of all the results: 24 months

• New markers

  From the beginning of the study to the analysis of all the results: 24 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with SLL/CLL who turned to the Hemolymphatic Pathology Unit of the IRCCS - Bologna University Hospital, Policlinico S. Orsola-Malpighi, and the Hemolymphatic Pathology Unit of the Pathological Anatomy Unit, Policlinico Universitario Umberto I, Rome, from January 2014 to December 2024.

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

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

Irccs Azienda Ospedaliero-Universitaria Di Bologna

Bologna, BOLOGNA, 40138, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Tissue. Formalin-fixed, paraffin-embedded samples

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Condition Hierarchy (Ancestors)

Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

ELENA SABATTINI, MD

CONTACT

+390512144562; elena.sabattini@aosp.bo.it

GIOVANNA MOTTA, BS

CONTACT

051214 3045; giovanna.motta@aosp.bo.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 18, 2025
• First Posted: January 2, 2026
• Study Start: December 31, 2025
• Primary Completion: February 28, 2026
• Study Completion (Estimated): August 31, 2027
• Last Updated: January 2, 2026

Record last verified: 2025-12

Locations

IT (1)