A Study of Chinese Adults With Lymphoma

NCT ID: NCT05288491

Last Updated: 2024-08-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

934 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-10-31

Study Completion Date

2024-06-20

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Lymphoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Takeda

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Study Director

Role: STUDY_DIRECTOR

Takeda

Locations

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Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Site Status

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Site Status

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Site Status

Fujian Cancer Hospital

Fuzhou, Fujian, China

Site Status

Fujian Medical University Union Hospital

Fuzhou, Fujian, China

Site Status

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Site Status

Henan Cancer Hospital

Zhengzhou, Henan, China

Site Status

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Site Status

Tongji Medical College of Hust

Wuhan, Hubei, China

Site Status

Jiangsu Province Hospital

Nanjing, Jiangsu, China

Site Status

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Site Status

Qilu Hospital of Shandong University

Jinan, Shandong, China

Site Status

Affiliated Hospital of Qingdao University

Qingdao, Shandong, China

Site Status

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Site Status

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

Site Status

Shanxi Cancer Hospital

Taiyuan, Shanxi, China

Site Status

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Site Status

Blood Disease Hospital, Chinese Academy of Medical Sciences

Tianjin, Tianjin Municipality, China

Site Status

Tianjin Medical University Cancer Hospital

Tianjin, Tianjin Municipality, China

Site Status

Countries

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China

Other Identifiers

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C25025

Identifier Type: -

Identifier Source: org_study_id

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