Serial Epstein-Barr Virus DNA Surveillance in Nasopharyngeal Carcinoma Patients

Sponsor

Sun Yat-sen University (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03855020

Collaborator

(none)

1,000

Enrollment

Location

59.8

Anticipated Duration (Months)

16.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Endemic nasopharyngeal carcinoma (NPC) is invariably associated with Epstein-barr virus (EBV) infection. Plasma EBV DAN detected by polymerase chain reaction (PCR)-based assays can provide important informations of disease screening, disease relapse, and risks classification. In this study, the investigators will explore the impact of serial plasma EBV DNA during chemotherapy and radiotherapy on initial tumor response and long-term survival in patients with non-metastatic nasopharyngeal carcinoma

Condition or Disease	Intervention/Treatment	Phase
Nasopharyngeal Carcinoma	Diagnostic Test: Plasma EBV DNA

Study Design

Study Type:

Observational

Anticipated Enrollment :

1000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Serial Epstein-Barr Virus DNA Surveillance During Treatment in Non-metastatic Nasopharyngeal Carcinoma Patients

Actual Study Start Date :

May 9, 2019

Anticipated Primary Completion Date :

May 10, 2022

Anticipated Study Completion Date :

May 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
observational cohort 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

Arm

Intervention/Treatment

observational cohort

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

Outcome Measures

Primary Outcome Measures

Progression-free survival [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.

Secondary Outcome Measures

overall survival [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 [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 [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 [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].

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients with newly histologically confirmed non-keratinizing carcinoma (according to WHO histological type)
No evidence of distant metastasis (M0)
Receive standard radical treatment
Not exhibiting overt psychopathology, and willing to participate and written informed consent was obtained

Exclusion Criteria:

WHO type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma.
Treatment with palliative intent
Previous chemotherapy or radiotherapy (except non-melanomatous skin cancers outside the intended RT treatment volume)
Severe intercurrent disease