Microenvironmental Trial of Classical Hodgkin Lymphoma in Adolescents

Completed

• Conditions: Classical Hodgkin Lymphoma

• Registration Number: NCT06814860
• Lead Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

Brief Summary

Background. Classical Hodgkin's lymphoma (cHL) in adolescents between 15 and 18 years shows a higher disease-related mortality and the overall prognosis is worse than both children and adults.

Objectives. To investigate the immune checkpoint inhibitors (ICPI) therapeutic targets and specific T-regulatory and cytotoxic T-cell subsets, in the subgroup of adolescent cHL patients and to investigate their prognostic power.

Methods: Retrieved formalin-fixed paraffin-embedded (FFPE) of adolescent patients diagnosed with cHL with available clinical and tested by immunohistochemistry the immune checkpoint molecules CTLA-4, LAG-3, PD-1 and PDL1 and the biological markers FOXP3 and CD8.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-02-07
• Primary Completion: 2024-05-23
• Study Completion: 2024-10-31
• Status Verified: 2024-12
• Study First Submitted: 2025-01-02
• Study First Submitted QC: 2025-02-03
• Last Update Submitted: 2025-02-03
• Study First Posted: 2025-02-07
• Last Update Posted: 2025-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• Patients aged 12 to 18 years at diagnosis of Classical Hodgkin lymphoma.

Exclusion Criteria

• Unavailability/insufficiency of histological material for diagnosis.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Characterization of the tumour microenvironment	through study completion, an average of 3 months	Identification of phenotypic markers with possible prognostic and/or therapeutic impact predictive of clinical outcomes in patients undergoing LHC in pediatric/adolescent age.

Trial Locations

Locations (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna; 🇮🇹 Bologna, Italy