A Study of Chinese Adults With Lymphoma (CREDIT)

Takeda

Status: Completed

Conditions: Lymphoma

Study type: Observational

Funder types: Industry

Identifiers

NCT05288491

C25025

Details and patient eligibility

About

The main aim of this study is to improve methods of clinical testing and therapy for lymphoma participants.

This study will involve collecting information about participants from past medical records.

Full description

This is an observational, non-interventional, retrospective study to evaluate staining and interpretation concordance of CD30 expression detected by 9 immunohistochemistry (IHC) assays and VENTANA CD30 IHC assay in Chinese lymphoma participants.

This study will enroll approximately 1000 participants. The data will be collected via chart review in the electronic case report forms (eCRFs). All the participants will be assigned to a single observational cohort:

• Participants With Malignant Lymphoma

This multi-center trial will be conducted in China. The overall duration of the study will be approximately 21 months.

Enrollment: 934 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Participants with diagnosis of cHL, ALCL, MF-LCT, DLBCL, PMBL, ENKTCL, PTCL-NOS, AITL and PCCD30+TCLPD.
2. Participants with available FFPE samples archived within 3 years.
3. Whose tissue slides of FFPE samples were previously IHC stained, their CD30 expression showed as well-localized positive stain and investigator deemed appropriate for evaluation.

Exclusion criteria

1. Sample is not sufficient for CD30 testing.
2. Incomplete sample information including key demographic characteristic, clinicopathological parameters and previous CD30 testing results.

Trial design

934 participants in 1 patient group

Participants With Malignant Lymphoma

Description:

All participants diagnosed with histopathologically confirmed malignant lymphoma will be enrolled and observed retrospectively. Complete medical information will be collected at the time of enrollment via chart review.