Serial Epstein-Barr Virus DNA Surveillance in Nasopharyngeal Carcinoma Patients

Active, not recruiting

• Conditions: Nasopharyngeal Carcinoma
• Interventions: Diagnostic Test: Plasma EBV DNA

• Registration Number: NCT03855020
• Lead Sponsor: Sun Yat-sen University

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-02-21
• Study First Submitted QC: 2019-02-23
• Study First Posted: 2019-02-26
• Study Start: 2019-05-09
• Primary Completion: 2022-05-10
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-16
• Last Update Posted: 2023-06-18
• Study Completion: 2024-05-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
observational cohort	Plasma EBV DNA	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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 \[t1/2 = 0.693/k\].
overall survival	3 years	Overall survival is calculated from the date of diagnosis of NPC to the date of death from any cause
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.
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.

Trial Locations

Locations (1)

Sun Yat-sen University Cancer Center; 🇨🇳 Guangzhou, Guangdong, China