Trial Title:
Different Molecular Subtypes of Peripheral T-cell Lymphoma, a Real-world Registry Study. (TRUST)
NCT ID:
NCT05934864
Condition:
Peripheral T Cell Lymphoma
Conditions: Official terms:
Lymphoma
Lymphoma, T-Cell
Lymphoma, T-Cell, Peripheral
Conditions: Keywords:
Peripheral T Cell Lymphoma
molecular subtypes
Study type:
Observational [Patient Registry]
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Genetic
Intervention name:
84-gene penal
Description:
84-gene penal was targeted sequenced in 1000 PTCL patients to investigate their mutation
profile and molecular subtypes.
Arm group label:
Gene mutation profile of PTCL
Summary:
A multi-center, prospective, registry study to analyze the clinical characteristics and
prognosis of different molecular subtypes of peripheral T-cell lymphoma.
Detailed description:
Peripheral T-cell lymphoma (PTCL）is a distinct and heterogeneous histopathologic subtype
of non-Hodgkin lymphoma (NHL), accounting for ~10%. Patients with PTCL still have poor
treatment response and prognosis under conventional CHOP regimen. This multi-center,
prospective, registry study is designed to analyze the clinical characteristics and
prognosis of different molecular subtypes of PTCL. The results can guide future precision
therapy for PTCL.
Criteria for eligibility:
Study pop:
The investigators reviewed previous PTCL genomics and PTCL registry studies worldwide.
And the number of PTCL patients admitted to each center per year was investigated. Sample
of 1000 PTCL patients was suitable and able to obtain a statistical significant result.
Sampling method:
Probability Sample
Criteria:
Inclusion Criteria:
- Patients diagnosed with peripheral T-cell lymphoma (PTCL) by histopathology from
June 2023 to December 2026 and detected by gene sequencing (NGS) with different
molecular subtypes.
- Patients diagnosed with PTCL by histopathology from January 2023 to June 2023 and
NGS detection can be performed if there is tumor tissue.
- Informed consented
- Age ≥ 18 years
Exclusion Criteria:
- History of malignancy except for basal cell or squamous cell carcinoma of the skin
or carcinoma in situ of the cervix prior to study treatment
- Uncontrollable cardio-cerebral vascular, coagulative, autoimmune, serious infectious
disease
- Not able to comply to the protocol for mental or other unknown reasons
- Patients with mentally disorders or other reasons unable to fully comply with the
study protocol
- Pregnant or lactation
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Peking University People's Hospital
Address:
City:
Beijing
Zip:
100044
Country:
China
Status:
Recruiting
Contact:
Last name:
Shenmiao Yang
Facility:
Name:
Henan Cancer Hospital
Address:
City:
Henan
Zip:
450003
Country:
China
Status:
Recruiting
Contact:
Last name:
Keshu Zhou
Facility:
Name:
Affiliated Drum Tower Hospital, Medical School of Nanjing University
Address:
City:
Nanjing
Zip:
210008
Country:
China
Status:
Recruiting
Contact:
Last name:
Jingyan Xu
Facility:
Name:
Department of Hematology, Shandong Provincial Hospital Affiliated to Shandong University, Jinan, China
Address:
City:
Shandong
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Xin Wang
Facility:
Name:
Shanghai Institute of Hematology, Rui-Jin Hospital affiliated to Shanghai Jiao Tong University School of Medicine
Address:
City:
Shanghai
Zip:
200025
Country:
China
Status:
Recruiting
Contact:
Last name:
Weili Zhao
Phone:
+862164370045
Phone ext:
610707
Email:
zwl_trial@163.com
Contact backup:
Last name:
Pengpeng Xu
Phone:
+862164370045
Phone ext:
610707
Email:
pengpeng_xu@126.com
Facility:
Name:
Department of Hematology, West China Hospital, Sichuan University, Chengdu, Sichuan, China
Address:
City:
Sichuan
Country:
China
Status:
Recruiting
Contact:
Last name:
Ting Niu
Start date:
July 13, 2023
Completion date:
June 1, 2026
Lead sponsor:
Agency:
Ruijin Hospital
Agency class:
Other
Collaborator:
Agency:
West China Hospital
Agency class:
Other
Collaborator:
Agency:
Shandong Provincial Hospital
Agency class:
Other
Collaborator:
Agency:
RenJi Hospital
Agency class:
Other
Collaborator:
Agency:
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Agency class:
Other
Collaborator:
Agency:
Tianjin Medical University Cancer Institute and Hospital
Agency class:
Other
Source:
Ruijin Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05934864
