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

NCT06321939 | Recruiting

• 1 other identifier: NPCNS 001
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Nasopharyngeal Carcinoma; Herpesvirus 4, Human

Outcome Measures

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.

  from diagnose to 4-8 weeks after definitive radiotherapy

Secondary Outcomes (6)

• Overall survival

  2 year

• Distant metastasis failure-free survival

  2 year

• Locoregional failure-free survival

  2 year

• Failure-free survival

  2 year

• Patient reported quality-of-life score

  up to 2 years

Interventions

EBV-DNA next generation sequencing DIAGNOSTIC_TEST

EBV-DNA next generation sequencing

Eligibility Criteria

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

Study Population

Non-metastatic NPC

You may qualify if:

• 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
• Receiving recommended curative intention treatments：definitive radiotherapy w/wo three cycles of induction chemotherapy (IC) (gemcitabine-cisplatin \[GP\] or paclitaxel-cisplatin \[TP\] regimen);
• Pre-treatment and post-IC1 cell-free Epstein-Barr virus (cfEBV) DNA \> 0 copy/mL; systemic cfEBV DNA monitoring during IC phase for risk stratification;
• Normal hematic, liver, and kidney function: hemoglobin (HG) \> 90 g/L; neutrophil \> 1.5 × 109/L; platelet \> 100 × 109/L; total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN); alanine transaminase (ALT) and aspartate transaminase (AST) ≤ 2.5 × ULN; alkaline phosphatase (ALP) ≤ 2.5 × ULN; creatinine clearance (Ccr) ≥ 60 mL/min;
• Female subjects capable of becoming pregnant agree to use reliable contraceptive measures from screening to 1 year after treatment;
• Patients will be required to sign informed consent forms and be willing and able to comply with the requirements for visits, treatment, laboratory tests, and other research requirements stipulated in the research schedule.

You may not qualify if:

• 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;
• Uncontrolled heart disease, e.g.: 1) Heart failure, New York Heart Association (NYHA) level ≥ 2; 2) unstable angina; 3) myocardial infarction in the past 1 year; 4) supraventricular or ventricular arrhythmia requiring treatment or intervention.

Sponsors & Collaborators

• Hunan Cancer Hospital: lead

Study Sites (1)

Hunan cancer Hospital

Changsha, Hunan, China

RECRUITING

MeSH Terms

Conditions

Nasopharyngeal Carcinoma; Epstein-Barr Virus Infections

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; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections

Central Study Contacts

Yaqian Han

CONTACT

(+86)18673176667; hanyaqian@hnca.org.cn

Study Design

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

Study Record Dates

• First Submitted: February 24, 2024
• First Posted: March 20, 2024
• Study Start: January 11, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2028
• Last Updated: March 20, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)