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

Sponsor
The First Affiliated Hospital with Nanjing Medical University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05343377
Collaborator
Zhenjiang First People's Hospital (Other), Changzhou First People's Hospital (Other), Changzhou Second People's Hospital (Other), Wuxi People's Hospital (Other), Second Affiliated Hospital of Soochow University (Other), The First Affiliated Hospital of Nantong University (Other), Huaian first people's hospital (Other), Yancheng First People's Hospital (Other)
72
Enrollment
1
Location
1
Arm
72
Anticipated Duration (Months)
1
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: circulate free methylated EBV DNA
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
72 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Screening
Official Title:
Prospective, Multicenter Clinical Study of Accurate Stratification and Prognostic Value of Circulating Free Methylated EBV DNA in Extranodal NK/T Cell Lymphoma
Anticipated Study Start Date :
Jun 1, 2022
Anticipated Primary Completion Date :
Jun 1, 2025
Anticipated Study Completion Date :
Jun 1, 2028

Arms and Interventions

Arm Intervention/Treatment
Experimental: circulate free methylated EBV DNA predicts PFS rate in ENKTCL

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 The First Affiliated Hospital of Nanjing Medical University Nanjing China

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
The First Affiliated Hospital with Nanjing Medical University
ClinicalTrials.gov Identifier:
NCT05343377
Other Study ID Numbers:
  • IRB-GL1-AF02
First Posted:
Apr 25, 2022
Last Update Posted:
Apr 25, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Lymphoma
Lymphoma, T-Cell
Lymphoma, T-Cell, Peripheral
Lymphoma, Extranodal NK-T-Cell

Study Results

No Results Posted as of Apr 25, 2022