Serial Epstein-Barr Virus DNA Surveillance in Nasopharyngeal Carcinoma Patients
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|ClinicalTrials.gov Identifier: NCT03855020|
Recruitment Status : Recruiting
First Posted : February 26, 2019
Last Update Posted : September 20, 2019
|Condition or disease||Intervention/treatment|
|Nasopharyngeal Carcinoma||Diagnostic Test: Plasma EBV DNA|
|Study Type :||Observational|
|Estimated Enrollment :||1000 participants|
|Official Title:||Serial Epstein-Barr Virus DNA Surveillance During Treatment in Non-metastatic Nasopharyngeal Carcinoma Patients|
|Actual Study Start Date :||May 9, 2019|
|Estimated Primary Completion Date :||May 10, 2022|
|Estimated Study Completion Date :||May 1, 2024|
Patients enrolled in this observational cohort would have regular blood taking for EBV DNA examination at baseline, after every cycle of chemotherapy, every week during radiotherapy, and 1-3 months after chemo-radiotherapy until EBV DNA becomes undetectable for at least two times.
Diagnostic Test: Plasma EBV DNA
Parameters analyzed will include (1) the changing pattern of plasma EBV DNA concentrations during chemotherapy and radiotherapy (2) half-life values (t1/2) of plasma EBV DNA clearance rate
- Progression-free survival [ Time Frame: 3 years ]Progression-free survival is calculated from the date of diagnosis of NPC to the date of progression of NPC or the date of death from any cause, whichever comes earlier.
- overall survival [ Time Frame: 3 years ]Overall survival is calculated from the date of diagnosis of NPC to the date of death from any cause
- Distant metastasis-free survival [ Time Frame: 3 years ]Distant metastasis-free survival is calculated from the date of diagnosis of NPC to the date of distant metastasis or date of death from any cause, whichever comes earlier.
- locoregional failure-free survival [ Time Frame: 3 years ]Local or regional failure-free survival is calculated from the date of diagnosis of NPC to the date of regional nodal failure or date of death from any cause, whichever comes earlier.
- EBV DNA clearance rate [ Time Frame: during the first month ]The half-life value (t1/2) of plasma EBV DNA clearance was calculated using the equation of [t1/2 = 0.693/k].
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03855020
|Contact: Ying Sun, M.D.||+86 email@example.com|
|Sun Yat-sen University Cancer Center||Recruiting|
|Guangzhou, Guangdong, China, 510060|
|Contact: Ying Sun, M.D. +86-020- 87343816 firstname.lastname@example.org|