Diagnosing PAX5‑negative Hodgkin‑like lymphomas
Official title: ANALISI DEI LINFOMI CON ASPETTO TIPO-HODGKIN A FENOTIPO ATIPICO PAX5 NEGATIVO
Run by IRCCS Azienda Ospedaliero-Universitaria di Bologna · NCT07313943 · Data updated 2026-11-12
This project tries to see if PAX5 staining combined with molecular and cytogenetic data can help doctors tell PAX5‑negative classical Hodgkin lymphoma apart from ALK‑negative anaplastic large‑cell lymphoma.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna Academic / other |
| Locations | 2 sites (Tübingen and 1 other locations) |
| Status | Recruiting |
| Started | December 30, 2025 |
| Main results expected | February 28, 2026 |
| Study ends | December 30, 2027 |
| Registry record updated | January 2, 2026 |
| Trial ID | NCT07313943 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults at initial diagnosis whose lymphoma shows a PAX5‑negative phenotype or an unclear distinction between PAX5‑negative classical Hodgkin lymphoma and ALK‑negative anaplastic large‑cell lymphoma, with available tissue and molecular/cytogenetic data, are ideal candidates.
✕Probably not a fit
Patients with clear-cut diagnoses (for example PAX5‑positive classical Hodgkin lymphoma or clearly identified ALCL) or without available tissue or molecular data are unlikely to benefit from this study.
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 collects pathology specimens and clinical information from adults whose lymphoma shows PAX5‑negative or ambiguous immunophenotypes. Expert pathologists will review morphology and perform immunohistochemistry (including PAX5, CD30, CD15, cytotoxic markers, and EMA) and compile available molecular and cytogenetic results. The focus is on cases where classical Hodgkin lymphoma has an atypical phenotype (PAX5‑negative) and the main differential diagnosis is ALK‑negative anaplastic large‑cell lymphoma. By correlating histology, immunophenotype, and molecular findings across cases from centers in Bologna and Tübingen, the study aims to refine diagnostic criteria and reduce misclassification.
Why it matters
Potential benefit: If successful, this work could improve diagnostic accuracy so patients receive the correct therapy sooner and avoid inappropriate treatment.
How similar studies have gone: Prior work has used PAX5 and cytotoxic/molecular markers to distinguish Hodgkin lymphoma from ALCL, but focused analyses of PAX5‑negative Hodgkin‑like cases are limited, so this study addresses a relatively underexplored diagnostic gap.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with lymphoma diagnosed as classic Hodgkin's lymphoma with a negative PAX5 marker * Patients with uncertain differential diagnosis between classical Hodgkin's lymphoma with atypical phenotype (PAX5 negative) and ALK-negative anaplastic large T-cell lymphoma (PAX5 negative) * Adult males and females at diagnosis * Availability of the molecular and/or cytogenetic data. Exclusion Criteria: * Patients with a diagnosis other than that under study, for whom clinical/histological/molecular information is not available
Where it's running
-
Universitätsklinikum Tübingen Institut für Pathologie
Tübingen, Germany Recruiting -
Irccs Azienda Ospedaliero-Universitaria Di 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.