NCT05318391

Translational Study of Molecular Classification of Relapsed/Refractory Diffuse Large B-cell Lymphoma

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 324 (actual)
• Sponsor: Shanghai Zhongshan Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to investigate the proportion of the cell-of-origin (COO) subtypes in relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL) treated with BTK inhibitor or lenalidomide and its biosimilars.

Detailed description

This is a multi-center, observational, retrospective study that examines approximately 200 R/R DLBCL patients treated with BTK inhibitors or lenalidomide and its biosimilars. For patients meet the inclusion criteria, gene expression analysis is performed on formalin fixed paraffin-embedded tissue by using Canhelp-COO Assay, and determine the COO subtype for each specimen. The proportion of COO subtypes in R/R DLBCL and the correlation between COO subtypes and clinicopathological information are further analyzed.

Conditions

• Lymphoma, Large B-Cell, Diffuse
• Gene Expression Profiling

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Gene expression profile	Diagnostic Test: The Canhelp-COO Assay (Canhelp Genomics CO., Ltd) for differentiating COO subtypes using gene expression analysis by real-time PCR (RT-PCR)

Timeline

• Start date: 2021-04-14
• Primary completion: 2022-01-30
• Completion: 2022-03-30
• First posted: 2022-04-08
• Last updated: 2022-04-08

Locations

1 site across 1 country: China