Serial Epstein-Barr Virus DNA Surveillance in Nasopharyngeal Carcinoma Patients

Nasopharyngeal Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03855020
• Other study ID #: 2019-FXY-015-radiation
• Status: Active, not recruiting
• Start date: May 9, 2019
• Est. completion date: May 1, 2024

Study information

• Verified date: June 2023
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1000
• Est. completion date: May 1, 2024
• Est. primary completion date: May 10, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Epstein-Barr Virus Infections
• Nasopharyngeal Carcinoma

Intervention

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

Locations

Country	Name	City	State
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival	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.	3 years
Secondary	overall survival	Overall survival is calculated from the date of diagnosis of NPC to the date of death from any cause	3 years
Secondary	Distant metastasis-free survival	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.	3 years
Secondary	locoregional failure-free survival	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.	3 years
Secondary	EBV DNA clearance rate	The half-life value (t1/2) of plasma EBV DNA clearance was calculated using the equation of [t1/2 = 0.693/k].	during the first month