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Sequencing-based Counting of Plasma Epstein-Barr Virus DNA in Non-metastatic Nasopharyngeal Carcinoma

ConditionsNasopharyngeal CarcinomaHerpesvirus 4, Human
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHunan Cancer Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Newly diagnosed, pathologically proven World Health Organization (WHO) type II/III untreated NPC;

Non-metastatic NPC (I-IVA, according to the 8th edition of the AJCC/UICC clinical staging system);

Age at diagnosis: over 18 years old;

Eastern Cooperative Oncology Group (ECOG) score: 0-1

Disqualifiers

Receiving surgery, target therapy, and/or immunotherapy during or before induction phase;

Other previous or concurrent malignant tumors, except adequately treated non-melanoma skin cancer, cervical carcinoma in situ, and thyroid papillary cancer;

Pregnant or lactating women (a pregnancy test should be considered for fertile women with an active sex life);

Previously treated with radical radiotherapy (RT), except non-melanoma skin cancers outside intended RT treatment volume;

Trial population

Non-metastatic NPC

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • EBV-DNA next generation sequencing

    Diagnostic test

    EBV-DNA next generation sequencing

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

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.

Time frame
from diagnose to 4-8 weeks after definitive radiotherapy

Secondary outcomes

1

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.

Time frame
2 year
2

Distant metastasis failure-free survival

Measured from the day of enrollment until death until distant metastasis , or the last follow-up visit.

Time frame
2 year
3

Locoregional failure-free survival

Measured from the day of enrollment until death until local and/or regional recurrence, or the last follow-up visit.

Time frame
2 year
4

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.

Time frame
2 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hunan Cancer Hospital

Lead sponsor

Source ClinicalTrials.gov
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