Back to resultsA Clinical Study of the Value of Circulating Free Methylated EBV DNA in Extranodal NK/T Cell Lymphoma
Primary Purpose
Extranodal Natural Killer/T-cell Lymphoma
Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
circulate free methylated EBV DNA
Sponsored by
About this trial
This is an interventional screening trial for Extranodal Natural Killer/T-cell Lymphoma
Eligibility Criteria
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
Sites / Locations
- The First Affiliated Hospital of Nanjing Medical University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
circulate free methylated EBV DNA predicts PFS rate in ENKTCL
Arm Description
Outcomes
Primary Outcome Measures
Assessing the accuracy of circulating free methylated EBV DNA in predicting 2-year PFS in patients with newly diagnosed ENKTCL
Secondary Outcome Measures
To assess the accuracy of circulating free methylated EBV DNA in predicting 2-year OS and CR rates in newly diagnosed ENKTCL patients
Full Information
NCT ID
NCT05343377
First Posted
April 19, 2022
Last Updated
April 19, 2022
Sponsor
The First Affiliated Hospital with Nanjing Medical University
Collaborators
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
1. Study Identification
Unique Protocol Identification Number
NCT05343377
Brief Title
A Clinical Study of the Value of Circulating Free Methylated EBV DNA in Extranodal NK/T Cell Lymphoma
Official Title
Prospective, Multicenter Clinical Study of Accurate Stratification and Prognostic Value of Circulating Free Methylated EBV DNA in Extranodal NK/T Cell Lymphoma
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 1, 2022 (Anticipated)
Primary Completion Date
June 1, 2025 (Anticipated)
Study Completion Date
June 1, 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The First Affiliated Hospital with Nanjing Medical University
Collaborators
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
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Extranodal Natural Killer/T-cell Lymphoma
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
72 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
circulate free methylated EBV DNA predicts PFS rate in ENKTCL
Arm Type
Experimental
Intervention Type
Diagnostic Test
Intervention Name(s)
circulate free methylated EBV DNA
Intervention Description
Accuracy of circulating free methylated EBV DNA in predicting 2-year PFS
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
wei xu
Phone
025-68306034
Email
xuwei10000@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
jinhua liang
Email
1151525490@qq.com
Facility Information:
Facility Name
The First Affiliated Hospital of Nanjing Medical University
City
Nanjing
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
wei xu
Phone
025-68306034
Email
xuwei10000@hotmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
A Clinical Study of the Value of Circulating Free Methylated EBV DNA in Extranodal NK/T Cell Lymphoma
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