Molecular Characterization and Outcomes of Aggressive B-Cell Lymphomas.

NCT ID: NCT07181785

Last Updated: 2025-09-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 555 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-07-12
• Study Completion Date: 2023-07-12

Brief Summary

This is a retrospective analysis of the presence of chromosomal rearrangements involving MYC, BCL2 and BCL6 genes by FISH in a retrospective, single-center series of large B-cell lymphomas, in order to allow a better classifications of these cases according to the current WHO 2017 classification. If this evaluation will be confirmed as a reliable method to reclassify in different groups the evaluated tumors, it can be subsequently routinely apply to indicate the best treatment approaches in this high-risk setting of patients with a significant impact on patients' morbidity and mortality, and also on the health system and related costs.

Conditions

Diffuse Large B Cell Lymphoma (DLBCL)

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: RETROSPECTIVE

Study Groups

Adult subjects (> 18 years old) of any age and gender affected by large B-cell lymphoma.

Histologically-confirmed diagnosis of LBCL (i.e., DLBCL, HGBCL, unclassifiable B-cell lymphoma with features intermediate between DLBCL and BL), or aggressive B-cell lymphomas with blastoid morphology (excluding blastoid variant of mantle cell lymphoma and lymphoblastic lymphoma)

• Histopathological diagnosis performed between 2000 and 2019.
• HIV sero-negativity
• Age ≥18
• Treatment with R-CHOP or other intensified polychemotherapy regimen
• Availability of adequate histopathological samples at diagnosis for FISH analysis
• Availability of clinical records and outcomes data

Treatments: anthracycline-based combinations followed or not by involved-field radiotherapy

Intervention Type: COMBINATION_PRODUCT

Anthracycline-based combinations followed or not by involved-field radiotherapy

Interventions

Treatments: anthracycline-based combinations followed or not by involved-field radiotherapy

Anthracycline-based combinations followed or not by involved-field radiotherapy

Intervention Type: COMBINATION_PRODUCT

Eligibility Criteria

Exclusion Criteria

• Histologic diagnosis other than DLBCL or unclassifiable B-cell lymphoma with features intermediate between DLBCL and BL

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Andrés José Maria Ferreri

OTHER

Sponsor Role: lead

Responsible Party

Andrés José Maria Ferreri

MD & Prof.

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

IRCCS San Raffaele Hospital

Milan, , Italy

Countries

Italy

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

CHARTHER

Identifier Type: -

Identifier Source: org_study_id