Brief Title
Serial Epstein-Barr Virus DNA Surveillance in Nasopharyngeal Carcinoma Patients
Official Title
Serial Epstein-Barr Virus DNA Surveillance During Treatment in Non-metastatic Nasopharyngeal Carcinoma Patients
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
Study Type
Observational
Primary Outcome
Progression-free survival
Secondary Outcome
overall survival
Condition
Nasopharyngeal Carcinoma
Intervention
Plasma EBV DNA
Study Arms / Comparison Groups
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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Diagnostic Test
Estimated Enrollment
1000
Start Date
May 9, 2019
Completion Date
May 1, 2024
Primary Completion Date
May 10, 2022
Eligibility Criteria
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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
, +86 87342253, [email protected]
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT03855020
Organization ID
2019-FXY-015-radiation
Responsible Party
Principal Investigator
Study Sponsor
Sun Yat-sen University
Study Sponsor
, ,
Verification Date
September 2019