Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The investigators aim to explore a new EBV DNA surveillance method with both high sensitivity and specificity in nasopharyngeal carcinoma (NPC) patients. the investigators aim to conduct plasma EBV DNA counting by next generation sequencing (NGS) in non-metastatic NPC patients on their diagnose, after two cycles of induction chemotherapy (IC), and 4-8 weeks after definitive radiotherapy. The investigators aim to explore whether sequencing-based counting is better than PCR analysis in plasma EBV-DNA surveillance, so as to monitoring tumor responses to treatment and for guiding individualized treatment adaptation in the future.
The investigators aim to explore a new EBV DNA surveillance method with both high sensitivity and specificity in nasopharyngeal carcinoma (NPC) patients. the investigators aim to conduct plasma EBV DNA counting by next generation sequencing (NGS) in non-metastatic NPC patients on their diagnose, after two cycles of induction chemotherapy (IC), and 4-8 weeks after definitive radiotherapy. The investigators aim to explore whether sequencing-based counting is better than PCR analysis in plasma EBV-DNA surveillance, so as to monitoring tumor responses to treatment and for guiding individualized treatment adaptation in the future.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EBV-DNA next generation sequencing | Diagnostic Test | EBV-DNA next generation sequencing |
| Measure | Description | Time Frame |
|---|---|---|
| Positivity rate of plasma EpsteineBarr virus (EBV) DNA by next generation sequencing | Plasma EBV DNA analysis by NGS on enrollment, after 2 cycles of induction chemotherapy, and 4-8 weeks after definitive radiotherapy. | from diagnose to 4-8 weeks after definitive radiotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | Measured from the day of enrollment until death due to any cause, or the last follow-upmeasured from the day of enrollment until death due to any cause, or the last follow-up visit. | 2 year |
| Distant metastasis failure-free survival |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Non-metastatic NPC
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yaqian Han | Contact | (+86)18673176667 | hanyaqian@hnca.org.cn |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hunan cancer Hospital | Recruiting | Changsha | Hunan | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000077274 | Nasopharyngeal Carcinoma |
| D020031 | Epstein-Barr Virus Infections |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
Not provided
Not provided
Measured from the day of enrollment until death until distant metastasis , or the last follow-up visit.
| 2 year |
| Locoregional failure-free survival | Measured from the day of enrollment until death until local and/or regional recurrence, or the last follow-up visit. | 2 year |
| Failure-free survival | Measured from the day of enrollment until treatment failure, death from any cause, or the last follow-up visit, whichever occurred first. | 2 year |
| Patient reported quality-of-life score | Patient reported quality of life would be evaluated using the Quality of Life Questionnaire-Core 30 module (QLQ-C30). | up to 2 years |
| Biomarker analysis | Exploratory biomarker analysis that would be able to predict patient treatment benefits, for example PD-L1 expression, antigen (other than EBV, eg. human cytomegalovirus(human cytomegalovirus [HCMV], TTV) DNA counting. | from diagnose to 4-8 weeks after definitive radiotherapy |
| D009303 |
| Nasopharyngeal Neoplasms |
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D009302 | Nasopharyngeal Diseases |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D014412 | Tumor Virus Infections |