CREDIT: A Study of Chinese Adults With Lymphoma

Sponsor

Takeda (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05288491

Collaborator

(none)

1,000

Enrollment

4.5

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lymphoma

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

Study Type:

Observational

Anticipated Enrollment :

1000 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

Concordance Study of CD30 Expression Detected by Multiple Immunohistochemistry Assays and VENTANA CD30 Assay in Chinese Lymphoma Patients

Anticipated Study Start Date :

Sep 30, 2022

Anticipated Primary Completion Date :

Feb 15, 2023

Anticipated Study Completion Date :

Feb 15, 2023

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

Percentage of Positive Cells for CD30 Expression Detected by 9 IHC Assays and VENTANA CD30 Assay [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 Outcome Measures

Percentage of Positive Cells for CD30 Expression Detected by IHC Assays and Interpreted by Pathologists [Up to 12 months]
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.
Percentage of Participants With Different Lymphoma Subtypes [Up to 12 months]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.

Exclusion Criteria:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Takeda

Investigators

Study Director: Study Director, Takeda

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Takeda

ClinicalTrials.gov Identifier:

NCT05288491

Other Study ID Numbers:

C25025

First Posted:

Mar 21, 2022

Last Update Posted:

Jun 8, 2022

Last Verified:

Jun 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Takeda

Drug Therapy

Additional relevant MeSH terms:

Lymphoma

Study Results

No Results Posted as of Jun 8, 2022