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

NCT06480903 | Not Yet Recruiting

• 1 other identifier: CFTSp237
• Study Type: observational
• Target: 10
• Locations: 0 countries
• Sites: N/A

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?

Conditions

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

Keywords

Nasopharyngeal, cancer, proton beam, epstein-barr virus

Outcome Measures

Primary Outcomes (1)

• Plasma EBV during proton beam RT

  Taken weekly, prior to each session of chemotherapy. Change in plasma EBV DNA levels (EBV VCA-IgM Ab) from each blood sample time point.

  6 weeks

Secondary Outcomes (1)

• EBV and tumour correlates

  2 years

Eligibility Criteria

• Age: 8 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Children, teenagers and young adults with nasopharyngeal carcinoma (age 8-30 years old)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• The Christie NHS Foundation Trust: lead

Related Publications (3)

• Twu CW, Wang WY, Liang WM, Jan JS, Jiang RS, Chao J, Jin YT, Lin JC. Comparison of the prognostic impact of serum anti-EBV antibody and plasma EBV DNA assays in nasopharyngeal carcinoma. Int J Radiat Oncol Biol Phys. 2007 Jan 1;67(1):130-7. doi: 10.1016/j.ijrobp.2006.07.012. Epub 2006 Sep 18.

  PMID: 16979842 BACKGROUND

• Chan AT, Lo YM, Zee B, Chan LY, Ma BB, Leung SF, Mo F, Lai M, Ho S, Huang DP, Johnson PJ. Plasma Epstein-Barr virus DNA and residual disease after radiotherapy for undifferentiated nasopharyngeal carcinoma. J Natl Cancer Inst. 2002 Nov 6;94(21):1614-9. doi: 10.1093/jnci/94.21.1614.

  PMID: 12419787 BACKGROUND

• Chan SK, Chan SY, Choi HC, Tong CC, Lam KO, Kwong DL, Vardhanabhuti V, Leung TW, Luk MY, Lee AW, Lee VH. Prognostication of Half-Life Clearance of Plasma EBV DNA in Previously Untreated Non-metastatic Nasopharyngeal Carcinoma Treated With Radical Intensity-Modulated Radiation Therapy. Front Oncol. 2020 Aug 21;10:1417. doi: 10.3389/fonc.2020.01417. eCollection 2020.

  PMID: 32974150 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Epstein-barr virus DNA, within blood samples

MeSH Terms

Conditions

Nasopharyngeal Carcinoma; Head and Neck Neoplasms; Nasopharyngeal Neoplasms; Epstein-Barr Virus Infections; Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections

Central Study Contacts

Shermaine Pan, Dr

CONTACT

01614463000; the-christie.sponsoredresearch@nhs.net

Christie NHS

CONTACT

01614463000; the-christie.sponsoredresearch@nhs.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2024
• First Posted: June 28, 2024
• Study Start: August 30, 2024
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): August 30, 2026
• Last Updated: June 28, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share