NCT05343377
Not yet recruiting
Not Applicable
Prospective, Multicenter Clinical Study of Accurate Stratification and Prognostic Value of Circulating Free Methylated EBV DNA in Extranodal NK/T Cell Lymphoma
The First Affiliated Hospital with Nanjing Medical University1 site in 1 country72 target enrollmentJune 1, 2022
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Extranodal Natural Killer/T-cell Lymphoma
- Sponsor
- The First Affiliated Hospital with Nanjing Medical University
- Enrollment
- 72
- Locations
- 1
- Primary Endpoint
- Assessing the accuracy of circulating free methylated EBV DNA in predicting 2-year PFS in patients with newly diagnosed ENKTCL
- Status
- Not yet recruiting
- Last Updated
- 4 years ago
Overview
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
Investigators
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
Outcomes
Primary Outcomes
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 Outcomes
- 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 Sites (1)
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