Clinical trial NCT05934864: Different Molecular Subtypes of Peripheral T-cell Lymphoma, a Real-world Registry Study. (TRUST)
Official title: Different Molecular Subtypes of Peripheral T-cell Lymphoma, a Real-world Registry Study. (TRUST Study)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Peripheral T Cell Lymphoma
Keywords: Peripheral T Cell Lymphoma
molecular subtypes
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
Collaborators: name: West China Hospital
name: Shandong Provincial Hospital
name: RenJi Hospital
name: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
name: Tianjin Medical University Cancer Institute and Hospital
First posted: 2023-07-07
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

Brief 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.

Eligibility 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

Primary outcomes:
measure: Progression-free survival
timeFrame: Baseline up to data cut-off (up to approximately 2 years)
Secondary outcomes:
measure: complete response rate
timeFrame: End of treatment visit (usually 6-8 weeks after last dose on Day 1 of Cycle 6 [Cycle length=21 days]
measure: Overall response rate
timeFrame: End of treatment visit (usually 6-8 weeks after last dose on Day 1 of Cycle 6 [Cycle length=21 days]
measure: Overall survival
timeFrame: Baseline up to data cut-off (up to approximately 4 years)
measure: Duration of response
timeFrame: Baseline up to data cut-off (up to approximately 4 years)
measure: Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE
timeFrame: Baseline up to data cut-off (up to approximately 4 years)
measure: Tumor tissue gene mutations analysis
timeFrame: Baseline up to data cut-off (up to approximately 4 years)
measure: Circulating free Deoxyribonucleic Acid (cfDNA) monitoring
timeFrame: Baseline up to data cut-off (up to approximately 4 years)
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
city: Henan
country: China
facility: Henan Cancer Hospital
city: Nanjing
country: China
facility: Affiliated Drum Tower Hospital, Medical School of Nanjing University
city: Shandong
country: China
facility: Department of Hematology, Shandong Provincial Hospital Affiliated to Shandong University, Jinan, China
city: Shanghai
country: China
facility: Shanghai Institute of Hematology, Rui-Jin Hospital affiliated to Shanghai Jiao Tong University School of Medicine
city: Sichuan
country: China
facility: Department of Hematology, West China Hospital, Sichuan University, Chengdu, Sichuan, China
Study officials:
References: