protocolSection identificationModule nctId: NCT06307314, orgStudyIdInfo id: NFEC-2024-093, briefTitle: Plasma SAA1 Levels in Predicting Response to Radiotherapy-induced Oral Mucositis, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-01, primaryCompletionDateStruct date: 2026-12-01, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Nanfang Hospital, Southern Medical University, class: OTHER, descriptionModule briefSummary: Head and neck squamous cell carcinoma (SCC) is the sixth most common cancer worldwide, with more than 700,000 new cases and more than 350,000 deaths each year. At present, radiotherapy is an important measure to control the recurrence of head and neck tumors, but almost all patients with head and neck squamous cell carcinoma will have acute inflammatory reactions such as radiotherapy-induced oral mucositis (RIOM) after radiotherapy, which seriously affects the quality of life and radiotherapy efficacy of patients. Serum amyloid A1 (SAA1) is an acute phase protein associated with inflammation. Our previous basic research found that serum SAA1 expression levels can be used as biomarkers to assess the dose received by the receptor in the early stages of radiation damage. At the same time, we confirmed that the serum level of SAA1 in patients with nasopharyngeal carcinoma increased after radiotherapy. Therefore, we intend to conduct a prospective, multicenter, observational study to further explore the predictive power of plasma SAA1 levels for radiotherapy-induced oral mucositis, with a view to early screening and prevention of RIOM patients., conditionsModule conditions: Nasopharyngeal Carcinoma, conditions: Head and Neck Cancer, conditions: Radiotherapy-induced Oral Mucositis, conditions: Biomarker, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 300, type: ESTIMATED, outcomesModule primaryOutcomes measure: Different grades radiotherapy-induced oral mucositis, secondaryOutcomes measure: Start and duration of radiotherapy-induced oral mucositis, secondaryOutcomes measure: Side effects of radiotherapy, secondaryOutcomes measure: Tumor response, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Nanfang hospital, Southern medical university, status: RECRUITING, city: Guangzhou, state: Guangdong, zip: 510515, country: China, contacts name: Jian Guan, Ph.D., role: CONTACT, geoPoint lat: 23.11667, lon: 113.25, locations facility: Fujian Provinical Hospital, status: NOT_YET_RECRUITING, city: Fuzhou, country: China, contacts name: Yongmei Dai, role: CONTACT, geoPoint lat: 26.06139, lon: 119.30611, locations facility: Huizhou Central People's Hospital, status: NOT_YET_RECRUITING, city: Huizhou, country: China, contacts name: Yunming Tian, role: CONTACT, geoPoint lat: 23.11147, lon: 114.41523, locations facility: Jieyang People's Hospital, status: NOT_YET_RECRUITING, city: Jieyang, country: China, contacts name: Peibao Lai, role: CONTACT, geoPoint lat: 23.5418, lon: 116.36581, locations facility: Meizhou People's Hospital, Meizhou Academy of Medical Sciences Meizhou, status: NOT_YET_RECRUITING, city: Meizhou, country: China, contacts name: Jianda Sun, role: CONTACT, geoPoint lat: 24.2886, lon: 116.11767, hasResults: False