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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants With Malignant Lymphoma | 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Positive Cells for CD30 Expression Detected by 9 IHC Assays and VENTANA CD30 Assay | 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. | Up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Positive Cells for CD30 Expression Detected by IHC Assays and Interpreted by Pathologists | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Chinese participants who have histopathologically confirmed or diagnosed with malignant lymphoma.
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Cancer Hospital | Beijing | Beijing Municipality | 100000 | China | ||
| Cancer Hospital, Chinese Academy of Medical Sciences |
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
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IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/ For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
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| ID | Term |
|---|---|
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
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| Up to 12 months |
| Percentage of Participants With Different Lymphoma Subtypes | 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. | Up to 12 months |
| Beijing |
| Beijing Municipality |
| 100000 |
| China |
| Peking Union Medical College Hospital | Beijing | Beijing Municipality | 100000 | China |
| Fujian Cancer Hospital | Fuzhou | Fujian | 350000 | China |
| Fujian Medical University Union Hospital | Fuzhou | Fujian | 350000 | China |
| Sun Yat-sen University Cancer Center | Guangzhou | Guangdong | 510000 | China |
| Henan Cancer Hospital | Zhengzhou | Henan | 450000 | China |
| The First Affiliated Hospital of Zhengzhou University | Zhengzhou | Henan | 450000 | China |
| Tongji Medical College of Hust | Wuhan | Hubei | 430000 | China |
| Jiangsu Province Hospital | Nanjing | Jiangsu | 210000 | China |
| The First Affiliated Hospital of Soochow University | Suzhou | Jiangsu | 215000 | China |
| Qilu Hospital of Shandong University | Jinan | Shandong | 250000 | China |
| Affiliated Hospital of Qingdao University | Qingdao | Shandong | 266000 | China |
| Fudan University Shanghai Cancer Center | Shanghai | Shanghai Municipality | 201321 | China |
| Zhongshan Hospital, Fudan University | Shanghai | Shanghai Municipality | 201321 | China |
| Shanxi Cancer Hospital | Taiyuan | Shanxi | 030000 | China |
| West China Hospital of Sichuan University | Chengdu | Sichuan | 610000 | China |
| Blood Disease Hospital, Chinese Academy of Medical Sciences | Tianjin | Tianjin Municipality | 300000 | China |
| Tianjin Medical University Cancer Hospital | Tianjin | Tianjin Municipality | 300000 | China |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |