A Study of Chinese Adults With Lymphoma | Clinical Trial

Key information

Conditions

Lymphoma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Beijing Cancer Hospital, Beijing, Beijing Municipality, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Participants with diagnosis of cHL, ALCL, MF-LCT, DLBCL, PMBL, ENKTCL, PTCL-NOS, AITL and PCCD30+TCLPD.
Participants with available FFPE samples archived within 3 years.
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

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

Treatment and study plan

Primary outcomes

Percentage of Positive Cells for CD30 Expression Detected by 9 IHC Assays and VENTANA CD30 Assay

Time frame: Up to 12 months

VENTANA CD30 assay (Ber-H2 (Ventana, Roche) + Ventana BenchMark) is standardized method preset in this study. The tissue slides from one Formalin-fixed and Paraffin-embedded (FFPE) samples will be stained by VENTANA CD30 IHC assay and at least one selected IHC assay. The staining concordance of percentage of CD30 positive cells for CD30 expression detected by 9 IHC assays and VENTANA CD30 assay will be respectively evaluated by intraclass correlation coefficient (ICC), Bland-Altman and Pearson correlation method. The selected 9 IHC assays will be used for evaluation of samples are: 1) umAB256 (Zhongshanjinqiao) + Ventana BenchMark, 2) Ber-H2 (Maixin) + Ventana BenchMark, 3) Ber-H2 (Maixin) + DAKO, 4) Ber-H2 (DAKO) + DAKO, 5) Ber-H2 (DAKO) + Ventana BenchMark, 6) umAB256 (Zhongshanjinqiao) + Leica, 7) JCM182 (Leica) + Ventana BenchMark, 8) JCM182 (Leica) + Leica, 9) Ber-H2 (DAKO) + Leica.

Secondary outcomes

Percentage of Positive Cells for CD30 Expression Detected by IHC Assays and Interpreted by Pathologists

Time frame: Up to 12 months

The tissue slides from one FFPE samples will be stained by VENTANA CD30 IHC assay and at least one selected IHC assay. CD30 expression of all immunostained slides will be independently interpreted as a percentage of CD30 positive cells by trained pathologists at sites. The interpreting concordance of pathologists at sites and the expert panel by assessing CD30 expression detected by various IHC assays will be also evaluated by ICC, Bland-Altman and Pearson correlation method.
Percentage of Participants With Different Lymphoma Subtypes

Time frame: Up to 12 months

The distribution of CD30 expression in Chinese lymphoma participants will be evaluated by percentage of Chinese participants with different lymphoma subtypes. Samples from participants with diagnosis of 9 lymphoma subtypes: Classical hodgkin's lymphoma (cHL), anaplastic large cell lymphoma (ALCL), large cell transformation of mycosis fungoides (MF-LCT), diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma (PMBL), extranodel nature killer or T cell lymphoma (ENKTCL), peripheral T cell lymphoma, not otherwise specified (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL) and primary cutaneous CD30-positive lymphoproliferative disorders (PCCD30+TCLPD) will be evaluated.

Sponsors and collaborators

Lead sponsor

Takeda

Industry

Registry information

Official study title

Concordance Study of CD30 Expression Detected by Multiple Immunohistochemistry Assays and VENTANA CD30 Assay in Chinese Lymphoma Patients

Acronym: CREDIT

Important dates

Study start: 2022
Primary completion: 2024
Study completion: 2024
First posted: Mar 21, 2022
Registry last updated: Aug 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed