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

NCT05343377 · tracked via the Priya Life Science China tracker

Sponsor

The First Affiliated Hospital with Nanjing Medical University

Phase

Not applicable

Started

2022-06-01

Last updated

2022-04-25

Condition(s) studied

Extranodal Natural Killer/T-cell Lymphoma

Investigational drug(s) / intervention(s)

circulate free methylated EBV DNA

circulate free methylated EBV DNA: Accuracy of circulating free methylated EBV DNA in predicting 2-year PFS

Study summary

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

Eligibility

Sex

ALL

Min age

18 Years

Max age

80 Years

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

Primary outcome measure(s)

Assessing the accuracy of circulating free methylated EBV DNA in predicting 2-year PFS in patients with newly diagnosed ENKTCL — 2 years

Trial sites (1)

Facility	City	Region	Status
The First Affiliated Hospital of Nanjing Medical University	Nanjing	China

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05343377 on ClinicalTrials.gov ↗ ← All trials in China