Trial Title:
A Study of People With CD30 Positive Lymphoma in China
NCT ID:
NCT05506774
Condition:
Lymphoma
Conditions: Official terms:
Lymphoma
Conditions: Keywords:
Drug Therapy
Study type:
Observational
Overall status:
Active, not recruiting
Study design:
Time perspective:
Retrospective
Summary:
The main aim is to see how adult participants with newly diagnosed or relapsed/refractory
CD30+ lymphoma responded to any previous treatment in China.
The study sponsor will not be involved in how participants are treated, the study only
consists of collecting demographic and clinical records information from the hospital
clinical systems. Based on the diagnosis of the disease, participants will be assigned to
one of the following groups and their information will be analyzed within that group
respectively:
- Group A: Participants diagnosed with classical Hodgkin lymphoma (cHL).
- Group B: participants diagnosed with non-Hodgkin lymphoma (NHL), including systemic
anaplastic large-cell lymphoma [sALCL], peripheral T-cell lymphoma-not otherwise
specified [PTCL-NOS], angioimmunoblastic T-cell lymphoma [AITL], extranodal
NK/T-cell lymphoma [ENKTCL], mycosis fungoides [MF], primary cutaneous anaplastic
large cell lymphoma [pcALCL], diffuse large B-cell lymphoma [DLBCL], primary
mediastinal B-cell lymphoma [PMBCL]).
Detailed description:
This is an observational, non-interventional, retrospective study in participants with
newly diagnosed or relapsed/refractory CD30+ lymphoma to describe the treatment pathways,
outcomes, and resource use among adult participants.
The study will enroll approximately 2800 participants. The data will be collected from
participants' medical records between January 1, 2018 and March 31, 2021 and recorded in
the in case report forms (CRFs). Participants will be assigned to the following two
observational cohorts based on pathological diagnosis:
- Cohort A: Participants with cHL
- Cohort B: Participants with NHL
This multi-center trial will be conducted in China. All participants will be observed for
at least 6 months or until death, loss to follow-up, or end of the study, whichever
occurs first.
Criteria for eligibility:
Study pop:
Participants diagnosed with CD30+ lymphoma (newly diagnosed or refractory/relapsed) and
treated between January 1, 2018 and March 31, 2021 will be enrolled in this study.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion criteria:
1. Who newly diagnosed with or refractory/relapsed with cHL, sALCL, CD30+ non-sALCL-NHL
confirmed by immunochemistry with any CD30 expression (that is, PTCL-NOS, AITL,
ENKTCL, MF, pcALCL, DLBCL, PMBCL) between January 1, 2018 and March 31, 2021 and
only one CD30+ pathology report will be needed for CD30+ non-sALCL-NHL.
2. Who have received anti-lymphoma treatment between January 1, 2018 and March 31,
2021.
Exclusion criteria:
1. Whose demographics and clinical features are not available from medical records.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Anhui Provincial Cancer Hospital
Address:
City:
Hefei
Zip:
230031
Country:
China
Facility:
Name:
Peking University Third Hospital
Address:
City:
Beijing
Zip:
100010
Country:
China
Facility:
Name:
The First Affiliated Hospital of Xiamen University
Address:
City:
Xiamen
Zip:
361003
Country:
China
Facility:
Name:
Union Hospital AffiliatedProf to Tongji Medical College, Huazhong University of Science and Technology
Address:
City:
Wuhan
Zip:
430022
Country:
China
Facility:
Name:
Tongji Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology
Address:
City:
Wuhan
Zip:
430030
Country:
China
Facility:
Name:
Jiangsu Province Hospital/the Firstaffiliated Hospital Withnanjing Medical University
Address:
City:
NanJing
Zip:
210000
Country:
China
Facility:
Name:
The Firstaffiliated Hospital Ofsoochow University
Address:
City:
SuZhou
Zip:
215000
Country:
China
Facility:
Name:
The First Affiliated Hospital of Nanchang University
Address:
City:
Nanchang
Zip:
330006
Country:
China
Facility:
Name:
Provincial Hospital Affiliated to Shandong First Medical University (Shandong Provincial Hospital)
Address:
City:
Shandong
Zip:
250000
Country:
China
Facility:
Name:
The First Affiliated Hospital of China Medical University
Address:
City:
ShenYang
Zip:
110002
Country:
China
Facility:
Name:
Shanghai Tongji Hospital
Address:
City:
Shanghai
Zip:
200065
Country:
China
Start date:
February 28, 2023
Completion date:
December 30, 2024
Lead sponsor:
Agency:
Takeda
Agency class:
Industry
Source:
Takeda
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05506774
