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

Exploratory Study of Plasma Epstein Barr Virus (EBV) DNA Clearance During Proton Beam Therapy (PBT) for Nasopharyngeal Carcinoma (NPC)

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06480903

Acronym

ClearED

Enrollment

Registered

2024-06-28

Start date

2024-08-30

Completion date

2026-08-30

Last updated

2024-06-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epstein-Barr Virus, Head and Neck Cancer, Nasopharyngeal Cancer, Nasopharyngeal Carcinoma

Keywords

Nasopharyngeal, cancer, proton beam, epstein-barr virus

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

8 Years to 30 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Contacts

Primary ContactShermaine Pan, Dr

the-christie.sponsoredresearch@nhs.net01614463000

Backup ContactChristie NHS