A Multi-center, Prospective, Registry Study to Analyze the Clinical Characteristics and Prognosis of Different Molecular Subtypes of Peripheral T-cell Lymphoma.

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorRuijin Hospital

About this trial

A multi-center, prospective, registry study to analyze the clinical characteristics and prognosis of different molecular subtypes of peripheral T-cell lymphoma.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients diagnosed with peripheral T-cell lymphoma (PTCL) by histopathology from June 2026 to December 2029 and detected by gene sequencing (NGS) with different molecular subtypes.

Patients diagnosed with PTCL by histopathology from January 2026 to June 2026 and NGS detection can be performed if there is tumor tissue.

Fully understand the study, voluntarily sign the written informed consent form (ICF), and agree to cooperate with genetic testing, treatment, efficacy assessment and long-term follow-up.

Age ≥ 18 years

Disqualifiers

Female patients who are pregnant, breastfeeding, or of childbearing potential without effective contraception;

Subjects with poorly controlled neurological, psychiatric, mental or cognitive disorders that may impair their understanding and signing of the informed consent form as well as adherence to the study procedures;

Any other conditions deemed inappropriate for enrollment by the investigator.

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Progression-free survival

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.

Time frame
Baseline up to data cut-off (up to approximately 4 years)

Secondary outcomes

1

Overall response rate

Percentage of participants with overall response was determined on the basis of investigator assessments according to 2014 Lugano criteria

Time frame
End of treatment visit (usually 6-8 weeks after last dose on Day 1 of Cycle 6 [Cycle length=21 days]
2

Complete response rate

Percentage of participants with complete response was determined on the basis of investigator assessments according to 2014 Lugano criteria.

Time frame
End of treatment visit (usually 6-8 weeks after last dose on Day 1 of Cycle 6 Cycle length=21 days]
3

Overall survival

Overall survival was defined as the time from the date of diagnosis to the date of death from any cause. Reported is the percentage of participants with event. of disease progression or relapse, using 2014 Lugano criteria,or death from any cause, whichever occurred first.

Time frame
Baseline up to data cut-off (up to approximately 4 years)
4

Duration of response

ime from first occurrence of documented CR or PR to disease progression/relapse, or death from any cause for participants with a response of CR or PR. Tumor assessments were performed with PET-CT.

Time frame
Baseline up to data cut-off (up to approximately 4 years)

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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