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

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?

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Key information

Conditions

Nasopharyngeal Carcinoma Carcinoma DNA Virus Infections Epstein-Barr Virus Epstein-Barr Virus Infections Head and Neck Cancer Head and Neck Neoplasms Herpesviridae Infections Infections Nasopharyngeal Cancer Nasopharyngeal Diseases Nasopharyngeal Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Pharyngeal Diseases Pharyngeal Neoplasms Stomatognathic Diseases Tumor Virus Infections Virus Diseases

Age range

8 year–30 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Plasma EBV during proton beam RT

Time frame: 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 outcomes

EBV and tumour correlates

Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Christie NHS

CONTACT

[email protected]

01614463000

Shermaine Pan, Dr

CONTACT

[email protected]

01614463000

Sponsors and collaborators

Lead sponsor

The Christie NHS Foundation Trust

Other

Registry information

Official study title

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

Acronym: ClearED

Important dates

Study start: 2024
Primary completion: 2026
Study completion: 2026
First posted: Jun 28, 2024
Registry last updated: Jun 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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