protocolSection identificationModule nctId: NCT06308328, orgStudyIdInfo id: NFEC-2024-090, briefTitle: A Real-world Observational Study of a Mucosal Contouring Method for Radiation-induced Oropharyngeal Mucositis, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2026-11-30, completionDateStruct date: 2027-01-31, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Nanfang Hospital, Southern Medical University, class: OTHER, descriptionModule briefSummary: The performance of the predictive models for the occurrence and severity of oropharyngeal mucositis established using either oral cavity contouring method or mucosa surface contouring method was unsatisfactory in nasopharyngeal carcinoma (NPC). Whereas the predictive model of a mucosal contouring method based on swallowing-induced breakthrough pain exhibited better overall performance in locally advanced NPC. Therefore, the investigators aimed to conduct a prospective, multicenter, real-world observational study to further assess the predictive efficacy of this mucosal delineation method for radiation-induced oropharyngeal mucositis in NPC., conditionsModule conditions: Radiation-induced Oropharyngeal Mucositis, conditions: Swallowing-induced Breakthrough Pain, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 718, type: ESTIMATED, outcomesModule primaryOutcomes measure: The AUC of the predictive model, secondaryOutcomes measure: The accuracy of the predictive model, secondaryOutcomes measure: The sensitivity of the predictive model, secondaryOutcomes measure: The specificity of the predictive model, secondaryOutcomes measure: The positive predictive value of the predictive model, secondaryOutcomes measure: The negative predictive value of the predictive model, secondaryOutcomes measure: The F1 score of the predictive model, secondaryOutcomes measure: The important predictors of severe oropharyngeal mucositis in the predictive model, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Affiliated Cancer Hospital & Institute of Guangzhou Medical University, status: NOT_YET_RECRUITING, city: Guangzhou, state: Guangdong, country: China, contacts name: Ronghui Zheng, role: CONTACT, geoPoint lat: 23.11667, lon: 113.25, locations facility: Nanfang hospital, Southern medical university, status: RECRUITING, city: Guangzhou, state: Guangdong, country: China, contacts name: Jian Guan, Ph.D., role: CONTACT, phone: 86+13632102247, email: guanjian5461@163.com, geoPoint lat: 23.11667, lon: 113.25, locations facility: Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, status: NOT_YET_RECRUITING, city: Guangzhou, state: Guangdong, country: China, contacts name: Yimin Liu, role: CONTACT, geoPoint lat: 23.11667, lon: 113.25, locations facility: Sun Yat-sen University Cancer Center, status: NOT_YET_RECRUITING, city: Guangzhou, state: Guangdong, country: China, contacts name: Linglong Tang, role: CONTACT, geoPoint lat: 23.11667, lon: 113.25, locations facility: The First Affiliated Hospital, Sun Yat-sen University, status: NOT_YET_RECRUITING, city: Guangzhou, state: Guangdong, country: China, contacts name: Yong Bao, role: CONTACT, geoPoint lat: 23.11667, lon: 113.25, locations facility: Yuebei People's Hospital, status: NOT_YET_RECRUITING, city: Shaoguan, state: Guangdong, country: China, contacts name: Suming Pan, role: CONTACT, geoPoint lat: 24.8, lon: 113.58333, locations facility: Peking University Shenzhen Hospital, status: NOT_YET_RECRUITING, city: Shenzhen, state: Guangdong, country: China, contacts name: Min Chen, role: CONTACT, geoPoint lat: 22.54554, lon: 114.0683, locations facility: The Fifth Affiliated Hospital, Sun Yat-sen University, status: NOT_YET_RECRUITING, city: Zhuhai, state: Guangdong, country: China, contacts name: Siyang Wang, role: CONTACT, geoPoint lat: 22.27694, lon: 113.56778, locations facility: Fudan University Shanghai Cancer Center, status: NOT_YET_RECRUITING, city: Shanghai, state: Shanghai, country: China, contacts name: Xueguan lv, role: CONTACT, geoPoint lat: 31.22222, lon: 121.45806, locations facility: Sichuan Cancer Hospital, status: NOT_YET_RECRUITING, city: Chendu, state: Sichuan, country: China, contacts name: Wenjun Liao, role: CONTACT, hasResults: False