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

The Christie NHS Foundation Trust

Status: Not yet enrolling

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

Study type: Observational

Funder types: Other

Identifiers

NCT06480903

CFTSp237

Details and patient eligibility

About

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?

Full 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.

Enrollment: 10 estimated patients

Sex: All

Ages: 8 to 30 years old

Volunteers: No Healthy Volunteers

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