Concordance Study of CD30 Expression Detected by Multiple Immunohistochemistry Assays and VENTANA CD30 Assay in Chinese Lymphoma Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 934
- 试验地点
- 19
- 主要终点
- Percentage of Positive Cells for CD30 Expression Detected by 9 IHC Assays and VENTANA CD30 Assay
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Sample is not sufficient for CD30 testing.
- •Incomplete sample information including key demographic characteristic, clinicopathological parameters and previous CD30 testing results.
结局指标
主要结局
Percentage of Positive Cells for CD30 Expression Detected by 9 IHC Assays and VENTANA CD30 Assay
时间窗: 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.
次要结局
- Percentage of Positive Cells for CD30 Expression Detected by IHC Assays and Interpreted by Pathologists(Up to 12 months)
- Percentage of Participants With Different Lymphoma Subtypes(Up to 12 months)