NCT06814860

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 7, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 23, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 2, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 7, 2025

Completed
Last Updated

February 7, 2025

Status Verified

December 1, 2024

Enrollment Period

4 months

First QC Date

January 2, 2025

Last Update Submit

February 3, 2025

Conditions

Classical Hodgkin Lymphoma

Keywords

Hodgkin Lymphomaadolescentmicroenvironmentimmune-check points

Outcome Measures

Primary Outcomes (1)

  • Characterization of the tumour microenvironment

    Identification of phenotypic markers with possible prognostic and/or therapeutic impact predictive of clinical outcomes in patients undergoing LHC in pediatric/adolescent age.

    through study completion, an average of 3 months

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients aged 12 to 18 years who were histologically diagnosed with Classical Hodgkin lymphoma between 01/01/1996 and 31/12/2020 will be enrolled in the study.

You may qualify if:

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

You may not qualify if:

  • Unavailability/insufficiency of histological material for diagnosis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Bologna, 40138, Italy

Location

Biospecimen

Retention: SAMPLES WITH DNA

Formalin fixed paraffin embedded (FFPE) samples

MeSH Terms

Conditions

Hodgkin Disease

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Elena Sabattini, MD

    IRCCS Azienda Ospedaliero-Universitaria di Bologna

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 2, 2025

First Posted

February 7, 2025

Study Start

February 7, 2024

Primary Completion

May 23, 2024

Study Completion

October 31, 2024

Last Updated

February 7, 2025

Record last verified: 2024-12

Locations

IT(1)