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

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05343377
Enrollment
72
Registered
2022-04-25
Start date
2022-06-01
Completion date
2028-06-01
Last updated
2022-04-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Extranodal Natural Killer/T-cell Lymphoma

Brief 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

Interventions

DIAGNOSTIC_TESTcirculate free methylated EBV DNA

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

Sponsors

Zhenjiang First People's Hospital
CollaboratorOTHER
Changzhou First People's Hospital
CollaboratorUNKNOWN
Changzhou Second People's Hospital
CollaboratorUNKNOWN
Wuxi People's Hospital
CollaboratorOTHER
Second Affiliated Hospital of Soochow University
CollaboratorOTHER
The First Affiliated Hospital of Nantong University
CollaboratorUNKNOWN
Huaian first people's hospital
CollaboratorUNKNOWN
Yancheng First People's Hospital
CollaboratorOTHER
The First Affiliated Hospital with Nanjing Medical University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Assessing the accuracy of circulating free methylated EBV DNA in predicting 2-year PFS in patients with newly diagnosed ENKTCL2 years

Secondary

MeasureTime frame
To assess the accuracy of circulating free methylated EBV DNA in predicting 2-year OS and CR rates in newly diagnosed ENKTCL patients2 years

Countries

China

Contacts

Primary Contactwei xu
xuwei10000@hotmail.com025-68306034
Backup Contactjinhua liang
1151525490@qq.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026