PAX5-NEGATIVE HODGKIN-LIKE LYMPHOMAS: A DIAGNOSTIC CHALLANGE

NCT07313943 | Recruiting

• 1 other identifier: HL PAX5- 2025
• Study Type: observational
• Target: 60
• Locations: 2 countries
• Sites: 2

Brief Summary

Hodgkin lymphoma (HL) is a lymphoma that arises from peripheral B lymphocytes. However, the neoplastic cells, Hodgkin cells and Reed-Sternberg cells, typically lack most B-cell markers, usually preserving the expression of the transcriptional factor PAX5, only phenotypic clue of B-cell origin. Morphologically similar cells to those diagnostic Hodgkin and Reed-Sternberg cells can also be observed in other lymphocytic proliferations, including Anaplastic Large Cell Lymphoma (ALCL), which originates from T lymphocytes and which share many features with HL, like strong CD30 expression and usually loss of T-cell markers. However, their clinical course is dramatically different with curability rates of \>90% for classical HL and an unfavorable prognosis for ALCL. PAX5 expression in HL and cytotoxic molecules expression in ALCL tumor cells may be a useful aid for diagnosis. However, in some cases the differential diagnosis is difficult owing to absence of these established markers. Furthermore, clonality analyses on classical HL were focused on Ig regions while TCR clonality has not yet been usefully explored. Studying the TCR clonal status of tumor cells, correlating it with a more comprehensive immunophenotypic profile and investigating the presence or absence of characteristic rearrangements (such as the JAK2 rearrangement, typical of ALCL lymphomas) could help to resolve the immuno-morphological overlap of the two entities and identify a possible repetitive pattern based on morphological, phenotypic and genetic characteristics. To this aim we intend to involve the Pathological Anatomy of Tubinga to increase the number of cases and achieve statistical significance, given the relative rarity of this entity

Conditions

Hodgkin or Non-Hodgkin Lymphoma

Outcome Measures

Primary Outcomes (1)

• Atypical Hodgkin Lymphoma

  To identify a characteristic morphological, phenotypic, and genetic pattern for lymphoma cases with an atypical Hodgkin lymphoma and to determine whether there are areas of overlap with ALK-negative anaplastic large cell lymphoma.

  6/12/24 months

Secondary Outcomes (1)

• Clinical-pathological correlations

  6/12/24 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

It is planned to enroll patients who have referred for diagnosis, from January 2014 to March 2025, at the following hospitals: 1) SSD of Hemolymphopathology IRCCS - Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola-Malpighi and 2) the Pathological Anatomy of Tübingen, Germany

You may qualify if:

• 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.

You may not qualify if:

• Patients with a diagnosis other than that under study, for whom clinical/histological/molecular information is not available

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (2)

Universitätsklinikum Tübingen Institut für Pathologie

Tübingen, 72076, Germany

RECRUITING

Irccs Azienda Ospedaliero-Universitaria Di Bologna

Bologna, 40138, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

tissue Formalin-fixed, paraffin-embedded samples

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

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 30, 2025
• Primary Completion: February 28, 2026
• Study Completion (Estimated): December 30, 2027
• Last Updated: January 2, 2026

Record last verified: 2025-12

Locations

DE (1); IT (1)