Clinical trial NCT05288491: A Study of Chinese Adults With Lymphoma
Official title: Concordance Study of CD30 Expression Detected by Multiple Immunohistochemistry Assays and VENTANA CD30 Assay in Chinese Lymphoma Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lymphoma
Keywords: Drug Therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2022-03-21
Enrollment: 934
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Chinese participants who have histopathologically confirmed or diagnosed with malignant lymphoma.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Positive Cells for CD30 Expression Detected by 9 IHC Assays and VENTANA CD30 Assay
timeFrame: Up to 12 months
Secondary outcomes:
measure: Percentage of Positive Cells for CD30 Expression Detected by IHC Assays and Interpreted by Pathologists
timeFrame: Up to 12 months
measure: Percentage of Participants With Different Lymphoma Subtypes
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
city: Beijing
country: China
facility: Cancer Hospital, Chinese Academy of Medical Sciences
state: Beijing
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
city: Fuzhou
country: China
facility: Fujian Cancer Hospital
state: Fujian
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital
state: Fujian
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
state: Henan
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
state: Henan
city: Wuhan
country: China
facility: Tongji Medical College of Hust
state: Hubei
city: Nanjing
country: China
facility: Jiangsu Province Hospital
state: Jiangsu
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University
state: Jiangsu
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
city: Qingdao
country: China
facility: Affiliated Hospital of Qingdao University
state: Shandong
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
city: Shanghai
country: China
facility: Zhongshan Hospital, Fudan University
state: Shanghai
city: Taiyuan
country: China
facility: Shanxi Cancer Hospital
state: Shanxi
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
state: Sichuan
city: Tianjin
country: China
facility: Blood Disease Hospital, Chinese Academy of Medical Sciences
state: Tianjin
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Hospital
state: Tianjin
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References: