Ignite Creation Date:
2025-12-24 @ 7:47 PM
Ignite Modification Date:
2026-02-19 @ 2:55 PM
Study NCT ID:
NCT06480903
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-28
First Post:
2024-06-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exploratory Study of EBV DNA Titre Clearance Whilst on Proton Beam Therapy
Sponsor:
The Christie NHS Foundation Trust
Organization:
Study Overview
Official Title:
Exploratory Study of Plasma Epstein Barr Virus (EBV) DNA Clearance During Proton Beam Therapy (PBT) for Nasopharyngeal Carcinoma (NPC)
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ClearED
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: