LEF1 levels as a diagnostic and survival marker in CLL/SLL
Official title: RILEVANZA DIAGNOSTICA DELLA ESPRESSIONE DI LEF-1 NEL LINFOMA A PICCOLI LINFOCITI/LEUCEMIA LINFATICA CRONICA B
Run by IRCCS Azienda Ospedaliero-Universitaria di Bologna · NCT07313982 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 350 (estimated) |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna Academic / other |
| Locations | 1 site (Bologna, BOLOGNA) |
| Status | Recruiting |
| Started | December 31, 2025 |
| Main results expected | February 28, 2026 |
| Study ends | August 31, 2027 |
| Registry record updated | January 2, 2026 |
| Trial ID | NCT07313982 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
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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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.