A Clinical Study of the Value of Circulating Free Methylated EBV DNA in Extranodal NK/T Cell Lymphoma
Not Applicable
Not yet recruiting
- Conditions
- Extranodal Natural Killer/T-cell Lymphoma
- Interventions
- Diagnostic Test: circulate free methylated EBV DNA
- Registration Number
- NCT05343377
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 72
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description circulate free methylated EBV DNA predicts PFS rate in ENKTCL circulate free methylated EBV DNA -
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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
Trial Locations
- Locations (1)
The First Affiliated Hospital of Nanjing Medical University
🇨🇳Nanjing, China