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
1 other identifier
interventional
72
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2022
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 19, 2022
CompletedFirst Posted
Study publicly available on registry
April 25, 2022
CompletedStudy Start
First participant enrolled
June 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2028
ExpectedApril 25, 2022
April 1, 2022
3 years
April 19, 2022
April 19, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Assessing the accuracy of circulating free methylated EBV DNA in predicting 2-year PFS in patients with newly diagnosed ENKTCL
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
2 years
Study Arms (1)
circulate free methylated EBV DNA predicts PFS rate in ENKTCL
EXPERIMENTALInterventions
Accuracy of circulating free methylated EBV DNA in predicting 2-year PFS
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- The investigator believes that the subjects may have other factors that may affect the efficacy or safety evaluation of this study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- The First Affiliated Hospital with Nanjing Medical Universitylead
- Zhenjiang First People's Hospitalcollaborator
- Changzhou First People's Hospitalcollaborator
- Changzhou Second People's Hospitalcollaborator
- Wuxi People's Hospitalcollaborator
- Second Affiliated Hospital of Soochow Universitycollaborator
- The First Affiliated Hospital of Nantong Universitycollaborator
- Huaian first people's hospitalcollaborator
- Yancheng First People's Hospitalcollaborator
Study Sites (1)
The First Affiliated Hospital of Nanjing Medical University
Nanjing, China
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 19, 2022
First Posted
April 25, 2022
Study Start
June 1, 2022
Primary Completion
June 1, 2025
Study Completion (Estimated)
June 1, 2028
Last Updated
April 25, 2022
Record last verified: 2022-04