Serial Epstein-Barr Virus DNA Surveillance in Nasopharyngeal Carcinoma Patients

NCT03855020 | Unknown

• 1 other identifier: 2019-FXY-015-radiation
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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

Conditions

Nasopharyngeal Carcinoma

Keywords

plasma EBV DNA; nasopharyngeal carcinoma; longitudinal surveillance

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• overall survival

  3 years

• Distant metastasis-free survival

  3 years

• locoregional failure-free survival

  3 years

• EBV DNA clearance rate

  during the first month

Study Arms (1)

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

Interventions

Plasma EBV DNA DIAGNOSTIC_TEST

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

observational cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with histologically confirmed, non-metastatic, previously untreated nasopharyngeal carcinoma (NPC) will be invited to join this study.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice-president

Study Record Dates

• First Submitted: February 21, 2019
• First Posted: February 26, 2019
• Study Start: May 9, 2019
• Primary Completion: May 10, 2022
• Study Completion: May 1, 2024
• Last Updated: June 18, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)