Exploratory Study of EBV DNA Titre Clearance Whilst on Proton Beam Therapy

Not yet recruiting

• Conditions: Nasopharyngeal Cancer; Nasopharyngeal Carcinoma; Epstein-Barr Virus; Head and Neck Cancer

• Registration Number: NCT06480903
• Lead Sponsor: The Christie NHS Foundation Trust

Brief Summary

How does plasma Epstein-Barr Virus (EBV) DNA level change during definitive radiation therapy for nasopharyngeal carcinoma (NPC) in the teenage and young adult cohort and does it correlate with outcomes?

Detailed Description

Children with NPC achieve superior survival outcomes compared to adults (10) and the prognostic value of plasma Epstein-Barr Virus (EBV) DNA has not been studied in children. Integration of MRI into early treatment response assessment will add further prognostic value and permits response-adapted therapy which can improve quality of survivorship children through toxicity reduction. It also allows identification of patients who either have had or are likely to have a suboptimal response to treatment, facilitating the potential consideration of treatment escalation.

The sample size of this study is not intended to change clinical practice, but rather provide a basis for international collaboration to achieve larger patient numbers.

Study Timeline

• Status Verified: 2024-06
• Study First Submitted: 2024-06-18
• Study First Submitted QC: 2024-06-25
• Last Update Submitted: 2024-06-25
• Study First Posted: 2024-06-28
• Last Update Posted: 2024-06-28
• Study Start: 2024-08-30
• Primary Completion: 2026-08-30
• Study Completion: 2026-08-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Children and young adults (8-30 years old)
• Pathologically confirmed EBV-positive nasopharyngeal carcinoma
• Stage I-IVA (AJCC 8th Edition)
• Planned to commence curative-intent radiation therapy

Exclusion Criteria

• Recurrent NPC
• Concurrent or previously treated EBV-associated malignancy
• Prior radiation therapy
• Contraindications to MRI
• General anaesthetic requirement for MRI

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Plasma EBV during proton beam RT	6 weeks	Taken weekly, prior to each session of chemotherapy. Change in plasma EBV DNA levels (EBV VCA-IgM Ab) from each blood sample time point.

Secondary Outcome Measures

Name	Time	Method
EBV and tumour correlates	2 years	Taken weekly, prior to each session of chemotherapy. Change in plasma EBV DNA levels (EBV VCA-IgM Ab) from each blood sample. Assessment whether EBV plasma clearance predicts tumour response.