Serial Epstein-Barr Virus DNA Surveillance in Nasopharyngeal Carcinoma Patients

NCT ID: NCT03855020

Last Updated: 2023-06-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-05-09

Study Completion Date

2024-05-01

Brief Summary

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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

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Conditions

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Nasopharyngeal Carcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Plasma EBV DNA

Intervention Type 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

Interventions

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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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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Ying Sun

Vice-president

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Site Status

Countries

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China

Other Identifiers

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2019-FXY-015-radiation

Identifier Type: -

Identifier Source: org_study_id

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