A Study of Chinese Adults With Lymphoma

Completed

Brief Summary: 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.

Detailed 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.

Recruitment & Eligibility

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.

Primary Outcome Measures

Name	Time	Method
Percentage of Positive Cells for CD30 Expression Detected by 9 IHC Assays and VENTANA CD30 Assay	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 Outcome Measures

Name	Time	Method
Percentage of Positive Cells for CD30 Expression Detected by IHC Assays and Interpreted by Pathologists	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	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.

Locations (19): Jiangsu Province Hospital
🇨🇳
Nanjing, Jiangsu, China
Shanxi Cancer Hospital
🇨🇳
Taiyuan, Shanxi, China
Tongji Medical College of Hust
🇨🇳
Wuhan, Hubei, China
Sun Yat-sen University Cancer Center
🇨🇳
Guangzhou, Guangdong, China
Henan Cancer Hospital
🇨🇳
Zhengzhou, Henan, China
The First Affiliated Hospital of Soochow University
🇨🇳
Suzhou, Jiangsu, China
Affiliated Hospital of Qingdao University
🇨🇳
Qingdao, Shandong, China
West China Hospital of Sichuan University
🇨🇳
Chengdu, Sichuan, China
Blood Disease Hospital, Chinese Academy of Medical Sciences
🇨🇳
Tianjin, Tianjin, China
Tianjin Medical University Cancer Hospital
🇨🇳
Tianjin, Tianjin, China
Beijing Cancer Hospital
🇨🇳
Beijing, Beijing, China
Peking Union Medical College Hospital
🇨🇳
Beijing, Beijing, China
Fujian Medical University Union Hospital
🇨🇳
Fuzhou, Fujian, China
Cancer Hospital, Chinese Academy of Medical Sciences
🇨🇳
Beijing, Beijing, China
The First Affiliated Hospital of Zhengzhou University
🇨🇳
Zhengzhou, Henan, China
Qilu Hospital of Shandong University
🇨🇳
Jinan, Shandong, China
Zhongshan Hospital, Fudan University
🇨🇳
Shanghai, Shanghai, China
Fudan University Shanghai Cancer Center
🇨🇳
Shanghai, Shanghai, China
Fujian Cancer Hospital
🇨🇳
Fuzhou, Fujian, China