LEF1 levels as a diagnostic and survival marker in CLL/SLL
RILEVANZA DIAGNOSTICA DELLA ESPRESSIONE DI LEF-1 NEL LINFOMA A PICCOLI LINFOCITI/LEUCEMIA LINFATICA CRONICA B
IRCCS Azienda Ospedaliero-Universitaria di Bologna · NCT07313982
We will test whether measuring LEF1 protein in lymph node, bone marrow, or other tissue samples can help diagnose and predict outcomes for adults with CLL/SLL.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 350 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna (other) |
| Locations | 1 site (Bologna, BOLOGNA) |
| Trial ID | NCT07313982 on ClinicalTrials.gov |
What this trial studies
This observational study measures LEF1 expression by immunohistochemistry on available lymph node, extranodal, or bone marrow tissue from adults with confirmed CLL/SLL and links those results to existing mutational and cytogenetic data. Investigators will correlate LEF1 levels with diagnostic features, genetic risk markers, and clinical outcomes including survival. The work uses existing patient samples and data collected at a single tertiary center in Bologna, Italy. No investigational treatments are administered as part of this protocol.
Who should consider this trial
Good fit: Adults with a confirmed diagnosis of CLL/SLL who have available lymph node, extranodal, or bone marrow tissue and submitted mutational and/or cytogenetic analysis data are ideal candidates.
Not a fit: Patients without an available biopsy/tissue sample or those whose diagnosis is not genetically supported as CLL/SLL are unlikely to benefit from this analysis.
Why it matters
Potential benefit: If successful, LEF1 testing could help doctors identify patients at higher risk and refine prognostic stratification to guide monitoring and treatment decisions.
How similar studies have performed: Previous research has reported LEF1 overexpression and Wnt pathway activation in CLL, so this work builds on existing findings rather than introducing an entirely novel marker.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Bologna, BOLOGNA
- Irccs Azienda Ospedaliero-Universitaria Di Bologna — Bologna, BOLOGNA, Italy (RECRUITING)
Study contacts
- Study coordinator: ELENA SABATTINI, MD
- Email: elena.sabattini@aosp.bo.it
- Phone: +390512144562
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Chronic Lymphocytic Leukemia / Small Lymphocytic Lymphoma