A Study of Chinese Adults With Lymphoma
CREDIT
Concordance Study of CD30 Expression Detected by Multiple Immunohistochemistry Assays and VENTANA CD30 Assay in Chinese Lymphoma Patients
1 other identifier
observational
934
1 country
19
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2022
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 15, 2022
CompletedFirst Posted
Study publicly available on registry
March 21, 2022
CompletedStudy Start
First participant enrolled
October 31, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 20, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 20, 2024
CompletedAugust 12, 2024
August 1, 2024
1.6 years
March 15, 2022
August 9, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (2)
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
Study Arms (1)
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.
Eligibility Criteria
Chinese participants who have histopathologically confirmed or diagnosed with malignant lymphoma.
You may qualify if:
- 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.
You may not qualify if:
- Sample is not sufficient for CD30 testing.
- Incomplete sample information including key demographic characteristic, clinicopathological parameters and previous CD30 testing results.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (19)
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100000, China
Cancer Hospital, Chinese Academy of Medical Sciences
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Study Director
Takeda
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 15, 2022
First Posted
March 21, 2022
Study Start
October 31, 2022
Primary Completion
June 20, 2024
Study Completion
June 20, 2024
Last Updated
August 12, 2024
Record last verified: 2024-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Access Criteria
- 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.
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.