Serial Epstein-Barr Virus DNA Surveillance in Nasopharyngeal Carcinoma Patients

Sun Yat-sen University

Status: Active, not recruiting

Conditions: Nasopharyngeal Carcinoma

Treatments: Diagnostic Test: Plasma EBV DNA

Study type: Observational

Funder types: Other

Identifiers

NCT03855020

2019-FXY-015-radiation

Details and patient eligibility

About

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

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

1,000 participants in 1 patient group

observational cohort

Description:

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.

Treatment:

Diagnostic Test: Plasma EBV DNA