---
title: A Study of Chinese Adults With Lymphoma
nct_id: NCT05288491
overall_status: COMPLETED
sponsor: Takeda
study_type: OBSERVATIONAL
primary_condition: Lymphoma
countries: China
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT05288491.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT05288491"
ct_last_update_post_date: 2024-08-12
last_seen_at: "2026-05-12T06:04:56.985Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# 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

**NCT ID:** [NCT05288491](https://clinicaltrials.gov/study/NCT05288491)

## Key Facts

- **Status:** COMPLETED
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 934
- **Lead Sponsor:** Takeda
- **Conditions:** Lymphoma
- **Start Date:** 2022-10-31
- **Completion Date:** 2024-06-20
- **CT.gov Last Update:** 2024-08-12

## 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

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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.
```

## Arms

- **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.

## Primary Outcomes

- **Percentage of Positive Cells for CD30 Expression Detected by 9 IHC Assays and VENTANA CD30 Assay** _(time frame: 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 Outcomes

- **Percentage of Positive Cells for CD30 Expression Detected by IHC Assays and Interpreted by Pathologists** _(time frame: Up to 12 months)_
- **Percentage of Participants With Different Lymphoma Subtypes** _(time frame: Up to 12 months)_

## Locations (19)

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

## Recent Field Changes (last 30 days)

- `locations.fujian cancer hospital|fuzhou|fujian|china` — added _(2026-05-12)_
- `locations.beijing cancer hospital|beijing|beijing municipality|china` — added _(2026-05-12)_
- `locations.cancer hospital, chinese academy of medical sciences|beijing|beijing municipality|china` — added _(2026-05-12)_
- `locations.peking union medical college hospital|beijing|beijing municipality|china` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.fujian medical university union hospital|fuzhou|fujian|china` — added _(2026-05-12)_
- `locations.sun yat-sen university cancer center|guangzhou|guangdong|china` — added _(2026-05-12)_
- `locations.henan cancer hospital|zhengzhou|henan|china` — added _(2026-05-12)_
- `locations.the first affiliated hospital of zhengzhou university|zhengzhou|henan|china` — added _(2026-05-12)_
- `locations.tongji medical college of hust|wuhan|hubei|china` — added _(2026-05-12)_
- `locations.jiangsu province hospital|nanjing|jiangsu|china` — added _(2026-05-12)_
- `locations.the first affiliated hospital of soochow university|suzhou|jiangsu|china` — added _(2026-05-12)_
- `locations.qilu hospital of shandong university|jinan|shandong|china` — added _(2026-05-12)_
- `locations.affiliated hospital of qingdao university|qingdao|shandong|china` — added _(2026-05-12)_
- `locations.fudan university shanghai cancer center|shanghai|shanghai municipality|china` — added _(2026-05-12)_
- `locations.zhongshan hospital, fudan university|shanghai|shanghai municipality|china` — added _(2026-05-12)_
- `locations.shanxi cancer hospital|taiyuan|shanxi|china` — added _(2026-05-12)_
- `locations.west china hospital of sichuan university|chengdu|sichuan|china` — added _(2026-05-12)_
- `locations.blood disease hospital, chinese academy of medical sciences|tianjin|tianjin municipality|china` — added _(2026-05-12)_
- `locations.tianjin medical university cancer hospital|tianjin|tianjin municipality|china` — added _(2026-05-12)_

---

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