Ignite Creation Date:
2025-12-24 @ 7:47 PM
Ignite Modification Date:
2026-03-03 @ 11:25 PM
Study NCT ID:
NCT06480903
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-28
First Post:
2024-06-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exploratory Study of EBV DNA Titre Clearance Whilst on Proton Beam Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077274', 'term': 'Nasopharyngeal Carcinoma'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D009303', 'term': 'Nasopharyngeal Neoplasms'}, {'id': 'D020031', 'term': 'Epstein-Barr Virus Infections'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D010610', 'term': 'Pharyngeal Neoplasms'}, {'id': 'D010039', 'term': 'Otorhinolaryngologic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009302', 'term': 'Nasopharyngeal Diseases'}, {'id': 'D010608', 'term': 'Pharyngeal Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D006566', 'term': 'Herpesviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014412', 'term': 'Tumor Virus Infections'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Epstein-barr virus DNA, within blood samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-08-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2026-08-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-25', 'studyFirstSubmitDate': '2024-06-18', 'studyFirstSubmitQcDate': '2024-06-25', 'lastUpdatePostDateStruct': {'date': '2024-06-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Plasma EBV during proton beam RT', 'timeFrame': '6 weeks', 'description': 'Taken weekly, prior to each session of chemotherapy. Change in plasma EBV DNA levels (EBV VCA-IgM Ab) from each blood sample time point.'}], 'secondaryOutcomes': [{'measure': 'EBV and tumour correlates', 'timeFrame': '2 years', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Nasopharyngeal, cancer, proton beam, epstein-barr virus'], 'conditions': ['Nasopharyngeal Carcinoma', 'Head and Neck Cancer', 'Nasopharyngeal Cancer', 'Epstein-Barr Virus']}, 'referencesModule': {'references': [{'pmid': '16979842', 'type': 'BACKGROUND', 'citation': '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': '12419787', 'type': 'BACKGROUND', 'citation': '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': '32974150', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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?', 'detailedDescription': '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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '30 Years', 'minimumAge': '8 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Children, teenagers and young adults with nasopharyngeal carcinoma (age 8-30 years old)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children and young adults (8-30 years old)\n* Pathologically confirmed EBV-positive nasopharyngeal carcinoma\n* Stage I-IVA (AJCC 8th Edition)\n* Planned to commence curative-intent radiation therapy\n\nExclusion Criteria:\n\n* Recurrent NPC\n* Concurrent or previously treated EBV-associated malignancy\n* Prior radiation therapy\n* Contraindications to MRI\n* General anaesthetic requirement for MRI'}, 'identificationModule': {'nctId': 'NCT06480903', 'acronym': 'ClearED', 'briefTitle': 'Exploratory Study of EBV DNA Titre Clearance Whilst on Proton Beam Therapy', 'organization': {'class': 'OTHER', 'fullName': 'The Christie NHS Foundation Trust'}, 'officialTitle': 'Exploratory Study of Plasma Epstein Barr Virus (EBV) DNA Clearance During Proton Beam Therapy (PBT) for Nasopharyngeal Carcinoma (NPC)', 'orgStudyIdInfo': {'id': 'CFTSp237'}}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Shermaine Pan, Dr', 'role': 'CONTACT', 'email': 'the-christie.sponsoredresearch@nhs.net', 'phone': '01614463000'}, {'name': 'Christie NHS', 'role': 'CONTACT', 'email': 'the-christie.sponsoredresearch@nhs.net', 'phone': '01614463000'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Aggregated data only'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Christie NHS Foundation Trust', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}