Skip to content

Serial Epstein-Barr Virus DNA Surveillance in Nasopharyngeal Carcinoma Patients

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03855020
Enrollment
1000
Registered
2019-02-26
Start date
2019-05-09
Completion date
2024-05-01
Last updated
2023-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nasopharyngeal Carcinoma

Keywords

plasma EBV DNA, nasopharyngeal carcinoma, longitudinal surveillance

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

Interventions

DIAGNOSTIC_TESTPlasma 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

Sponsors

Sun Yat-sen University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Progression-free survival3 yearsProgression-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

MeasureTime frameDescription
overall survival3 yearsOverall survival is calculated from the date of diagnosis of NPC to the date of death from any cause
Distant metastasis-free survival3 yearsDistant 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 survival3 yearsLocal 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 rateduring the first monthThe half-life value (t1/2) of plasma EBV DNA clearance was calculated using the equation of \[t1/2 = 0.693/k\].

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 13, 2026