Nasopharyngeal CarcinomaClearEDNCT06480903
Exploratory Study of EBV DNA Titre Clearance Whilst on Proton Beam Therapy
An observational study of Nasopharyngeal Carcinoma and Head and Neck Cancer, run by The Christie NHS Foundation Trust.
Trial 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? Read more about this study
- Who is it for?
- Ages 8 to 30 years
- Conditions the study is for
- Nasopharyngeal Carcinoma, Head and Neck Cancer, Nasopharyngeal Cancer
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 30 Aug 2024to 30 Aug 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children, teenagers and young adults with nasopharyngeal carcinoma (age 8-30 years old)
Who may be able to join
- 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
Who cannot join
- Recurrent NPC
- Concurrent or previously treated EBV-associated malignancy
- Prior radiation therapy
- Contraindications to MRI
- General anaesthetic requirement for MRI
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Exploratory Study of Plasma Epstein Barr Virus (EBV) DNA Clearance During Proton Beam Therapy (PBT) for Nasopharyngeal Carcinoma (NPC)
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?
Read the 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.
- Keywords
- Nasopharyngeal, cancer, proton beam, epstein-barr virus
- Medical subject headings
- Nasopharyngeal Carcinoma, Head and Neck Neoplasms, Nasopharyngeal Neoplasms, Epstein-Barr Virus Infections, Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks
Secondary outcomes (1)
EBV and tumour correlates
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2024
- Study start30 Aug 2024 (estimated)
- Primary completion30 Aug 2026 (estimated)
- Study completion30 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Nasopharyngeal CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Christie NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06480903
- Sponsor's protocol ID
- CFTSp237
- Acronym
- ClearED
- Status last verified
- Jun 2024
- First submitted
- 18 Jun 2024
- Last updated
- 28 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Aggregated data only
Publications
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.
PubMed 16979842Chan 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.
PubMed 12419787Chan 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.
PubMed 32974150
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Study of Plasma Epstein Barr Virus (EBV) DNA Clearance During Proton Beam Therapy (PBT) for Nasopharyngeal Carcinoma (NPC)
- ClinicalTrials.gov ID
- NCT06480903
- Acronym / sponsor ID
- ClearED / CFTSp237
- Keywords
- Nasopharyngeal, cancer, proton beam, epstein-barr virus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- The Christie NHS Foundation TrustUniversity, hospital or other
- Study start
- 30 Aug 2024 (estimated)
- Primary completion
- 30 Aug 2026 (estimated)
- Study completion
- 30 Aug 2026 (estimated)
- First posted
- 28 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 8 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children, teenagers and young adults with nasopharyngeal carcinoma (age 8-30 years old)
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- Recurrent NPC
- Concurrent or previously treated EBV-associated malignancy
- Prior radiation therapy
- Contraindications to MRI
- General anaesthetic requirement for MRI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
EBV and tumour correlates
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2024.
- Background: PubMed 16979842Twu 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.
- Background: PubMed 12419787Chan 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.
- Background: PubMed 32974150Chan 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.
- Individual participant dataSharing planned: No. Aggregated data only
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Nasopharyngeal Carcinoma and Head and Neck Cancer, run by The Christie NHS Foundation Trust.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shermaine Pan, Dr (01614463000, the-christie.sponsoredresearch@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma EBV during proton beam RT (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06480903, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2024.