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

NCT ID: NCT06480903

Last Updated: 2024-06-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-08-30

Study Completion Date

2026-08-30

Brief Summary

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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

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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.

Conditions

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

Keywords

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Nasopharyngeal, cancer, proton beam, epstein-barr virus

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

8 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Christie NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Shermaine Pan, Dr

Role: CONTACT

Phone: 01614463000

Email: [email protected]

Christie NHS

Role: CONTACT

Phone: 01614463000

Email: [email protected]

References

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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.

Reference Type BACKGROUND
PMID: 16979842 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12419787 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32974150 (View on PubMed)

Other Identifiers

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CFTSp237

Identifier Type: -

Identifier Source: org_study_id