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

NCT ID: NCT05343377

Last Updated: 2022-04-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-01

Study Completion Date

2028-06-01

Brief Summary

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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

Detailed Description

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Conditions

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Extranodal Natural Killer/T-cell Lymphoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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circulate free methylated EBV DNA predicts PFS rate in ENKTCL

Group Type EXPERIMENTAL

circulate free methylated EBV DNA

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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circulate free methylated EBV DNA

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zhenjiang First People's Hospital

OTHER

Sponsor Role collaborator

Changzhou First People's Hospital

UNKNOWN

Sponsor Role collaborator

Changzhou Second People's Hospital

UNKNOWN

Sponsor Role collaborator

Wuxi People's Hospital

OTHER

Sponsor Role collaborator

Second Affiliated Hospital of Soochow University

OTHER

Sponsor Role collaborator

The First Affiliated Hospital of Nantong University

UNKNOWN

Sponsor Role collaborator

Huaian first people's hospital

UNKNOWN

Sponsor Role collaborator

Yancheng First People's Hospital

OTHER

Sponsor Role collaborator

The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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The First Affiliated Hospital of Nanjing Medical University

Nanjing, , China

Site Status

Countries

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China

Central Contacts

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wei xu

Role: CONTACT

025-68306034

jinhua liang

Role: CONTACT

Facility Contacts

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wei xu

Role: primary

025-68306034

Other Identifiers

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IRB-GL1-AF02

Identifier Type: -

Identifier Source: org_study_id

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