LymphomaCREDITNCT05288491
A Study of Chinese Adults With Lymphoma
An observational study of Lymphoma, run by Takeda at 19 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma
- How many people
- 934 participants
- Where
- 19 sitesChina
- Study dates
- 31 Oct 2022to 20 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Chinese participants who have histopathologically confirmed or diagnosed with malignant lymphoma.
Who may be able to join
- 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.
Who cannot join
- Sample is not sufficient for CD30 testing.
- Incomplete sample information including key demographic characteristic, clinicopathological parameters and previous CD30 testing results.
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
China19 sites
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100000
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100000
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100000
West China Hospital of Sichuan University
Chengdu, Sichuan, 610000
Fujian Cancer Hospital
Fuzhou, Fujian, 350000
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350000
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510000
Qilu Hospital of Shandong University
Jinan, Shandong, 250000
Jiangsu Province Hospital
Nanjing, Jiangsu, 210000
Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266000
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 201321
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 201321
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215000
Shanxi Cancer Hospital
Taiyuan, Shanxi, 030000
Blood Disease Hospital, Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, 300000
Tianjin Medical University Cancer Hospital
Tianjin, Tianjin Municipality, 300000
Tongji Medical College of Hust
Wuhan, Hubei, 430000
Henan Cancer Hospital
Zhengzhou, Henan, 450000
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450000
About this study
Official title: Concordance Study of CD30 Expression Detected by Multiple Immunohistochemistry Assays and VENTANA CD30 Assay in Chinese Lymphoma Patients
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.
Read the 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.
- Conditions
- Lymphoma
- Keywords
- Drug Therapy
- Medical subject headings
- Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 12 months
Secondary outcomes (2)
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.
Measured: 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.
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2022
- Study start31 Oct 2022
- Primary completion20 Jun 2024
- Study completion20 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphomaStudies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 934 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05288491
- Sponsor's protocol ID
- C25025
- Acronym
- CREDIT
- Status last verified
- Aug 2024
- First submitted
- 15 Mar 2022
- Last updated
- 12 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Concordance Study of CD30 Expression Detected by Multiple Immunohistochemistry Assays and VENTANA CD30 Assay in Chinese Lymphoma Patients
- ClinicalTrials.gov ID
- NCT05288491
- Acronym / sponsor ID
- CREDIT / C25025
- Conditions
- Lymphoma
- Keywords
- Drug Therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 934 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- 31 Oct 2022 (actual)
- Primary completion
- 20 Jun 2024 (actual)
- Study completion
- 20 Jun 2024 (actual)
- First posted
- 21 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Chinese participants who have histopathologically confirmed or diagnosed with malignant lymphoma.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Sample is not sufficient for CD30 testing.
- Incomplete sample information including key demographic characteristic, clinicopathological parameters and previous CD30 testing results.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2024.
- Individual participant dataSharing planned: Yes. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Director study director
Takeda
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lymphoma, run by Takeda at 19 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Positive Cells for CD30 Expression Detected by 9 IHC Assays and VENTANA CD30 Assay (time frame: Up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2024.