A Clinical Study of the Value of Circulating Free Methylated EBV DNA in Extranodal NK/T Cell Lymphoma

Nanjing Medical University

Status: Not yet enrolling

Conditions: Extranodal Natural Killer/T-cell Lymphoma

Treatments: Diagnostic Test: circulate free methylated EBV DNA

Study type: Interventional

Funder types: Other

Identifiers

NCT05343377

IRB-GL1-AF02

Details and patient eligibility

About

This study is a prospective, multicenter, open-label, single-arm clinical study. This study plans to enroll 72 newly diagnosed ENKTCL patients. The enrollment was completed in 2 years, and the follow-up was terminated in 4 years. To observe the accuracy of circulating free methylated EBV DNA in predicting 2-year PFS rate, 2-year OS rate, and CR rate in newly diagnosed ENKTCL patients; and to clarify the prognostic stratification ability of PINK-cpgE compared with PINK-E

Enrollment: 72 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• newly diagnosed ENKTCL confirmed by pathological tissue, the diagnostic criteria refer to the 2016 WHO diagnostic criteria
• Sign written informed consent and be able to comply with the visits and related procedures specified in the protocol

Exclusion criteria

• The investigator believes that the subjects may have other factors that may affect the efficacy or safety evaluation of this study

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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72 participants in 1 patient group

circulate free methylated EBV DNA predicts PFS rate in ENKTCL

Experimental group

Treatment:

Diagnostic Test: circulate free methylated EBV DNA