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NCT Number: NCT05343377

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

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

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Key information

Conditions

Extranodal Natural Killer/T-Cell Lymphoma

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

circulate free methylated EBV DNA

Diagnostic Test

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

Primary outcomes

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

    Time frame: 2 years

Secondary outcomes

  1. To assess the accuracy of circulating free methylated EBV DNA in predicting 2-year OS and CR rates in newly diagnosed ENKTCL patients

    Time frame: 2 years

Study contacts

Contact information is provided by the study sponsor or research team.

jinhua liang

CONTACT

[email protected]

wei xu

CONTACT

[email protected]

025-68306034

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital with Nanjing Medical University

Other

Collaborators

  • Affiliated Hospital of Nantong University
  • Changzhou First People's Hospital
  • Changzhou Second People's Hospital
  • Huai'an First People's Hospital
  • Second Affiliated Hospital of Soochow University
  • Wuxi People's Hospital
  • Yancheng First People's Hospital
  • Zhenjiang First People's Hospital

Registry information

Official study title

Prospective, Multicenter Clinical Study of Accurate Stratification and Prognostic Value of Circulating Free Methylated EBV DNA in Extranodal NK/T Cell Lymphoma

Important dates

Study start
2022
Primary completion
2025
Study completion
2028
First posted
Apr 25, 2022
Registry last updated
Apr 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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