Different Molecular Subtypes of Peripheral T-cell Lymphoma, a Real-world Registry Study. (TRUST)
1 other identifier
observational
1,000
1 country
6
Brief Summary
A multi-center, prospective, registry study to analyze the clinical characteristics and prognosis of different molecular subtypes of peripheral T-cell lymphoma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2023
Typical duration for all trials
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 13, 2023
CompletedFirst Posted
Study publicly available on registry
July 7, 2023
CompletedStudy Start
First participant enrolled
July 13, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2026
ExpectedMay 16, 2024
May 1, 2024
1.9 years
June 13, 2023
May 14, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression-free survival
Progression-free survival was defined as the time from the date of randomization until the date of the first documented day of disease progression or relapse, using 2014 Lugano criteria, or death from any cause, whichever occurred first.
Baseline up to data cut-off (up to approximately 2 years)
Secondary Outcomes (7)
complete response rate
End of treatment visit (usually 6-8 weeks after last dose on Day 1 of Cycle 6 [Cycle length=21 days]
Overall response rate
End of treatment visit (usually 6-8 weeks after last dose on Day 1 of Cycle 6 [Cycle length=21 days]
Overall survival
Baseline up to data cut-off (up to approximately 4 years)
Duration of response
Baseline up to data cut-off (up to approximately 4 years)
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE
Baseline up to data cut-off (up to approximately 4 years)
- +2 more secondary outcomes
Study Arms (1)
Gene mutation profile of PTCL
84-gene penal was targeted sequenced in 1000 PTCL patients to investigate their mutation profile and molecular subtypes.
Interventions
84-gene penal was targeted sequenced in 1000 PTCL patients to investigate their mutation profile and molecular subtypes.
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ruijin Hospitallead
- West China Hospitalcollaborator
- Shandong Provincial Hospitalcollaborator
- RenJi Hospitalcollaborator
- Xinhua Hospital, Shanghai Jiao Tong University School of Medicinecollaborator
- Tianjin Medical University Cancer Institute and Hospitalcollaborator
Study Sites (6)
Peking University People's Hospital
Beijing, 100044, China
Henan Cancer Hospital
Henan, 450003, China
Affiliated Drum Tower Hospital, Medical School of Nanjing University
Nanjing, 210008, China
Department of Hematology, Shandong Provincial Hospital Affiliated to Shandong University, Jinan, China
Shandong, China
Shanghai Institute of Hematology, Rui-Jin Hospital affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, 200025, China
Department of Hematology, West China Hospital, Sichuan University, Chengdu, Sichuan, China
Sichuan, China
Biospecimen
Targeted sequencing was performed in fresh tissue or FFPE tissue quality controlled.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 2 Years
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Deputy Director of Hospital, Shanghai Rui Jin Hospital
Study Record Dates
First Submitted
June 13, 2023
First Posted
July 7, 2023
Study Start
July 13, 2023
Primary Completion
June 1, 2025
Study Completion (Estimated)
June 1, 2026
Last Updated
May 16, 2024
Record last verified: 2024-05
Data Sharing
- IPD Sharing
- Will not share