Ignite Creation Date:
2025-12-25 @ 12:43 AM
Ignite Modification Date:
2025-12-25 @ 10:56 PM
Study NCT ID:
NCT06032767
Status:
RECRUITING
Last Update Posted:
2024-01-05
First Post:
2023-09-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prospective Observational Study to Predict Severe Oral Mucositis Associated With Chemoradiotherapy in Nasopharyngeal Carcinoma Based on Deep Learning
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077274', 'term': 'Nasopharyngeal Carcinoma'}, {'id': 'D013280', 'term': 'Stomatitis'}], 'ancestors': [{'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009303', 'term': 'Nasopharyngeal Neoplasms'}, {'id': 'D010610', 'term': 'Pharyngeal Neoplasms'}, {'id': 'D010039', 'term': 'Otorhinolaryngologic Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck 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': 'D009059', 'term': 'Mouth Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 480}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-08-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2024-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-04', 'studyFirstSubmitDate': '2023-09-04', 'studyFirstSubmitQcDate': '2023-09-11', 'lastUpdatePostDateStruct': {'date': '2024-01-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'RTOG/EROTC Acute Radiation Reaction Scoring Standard', 'timeFrame': 'through radiation therapy, an average of 7 weeks', 'description': 'Toxicity records of oral mucosal Reaction in patients are conducted by professionally trained oncologists'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Nasopharyngeal Carcinoma', 'Oral Mucositis', 'deep learning'], 'conditions': ['Nasopharyngeal Carcinoma', 'Oral Mucositis']}, 'referencesModule': {'references': [{'pmid': '15936155', 'type': 'RESULT', 'citation': 'Wolden SL, Chen WC, Pfister DG, Kraus DH, Berry SL, Zelefsky MJ. Intensity-modulated radiation therapy (IMRT) for nasopharynx cancer: update of the Memorial Sloan-Kettering experience. Int J Radiat Oncol Biol Phys. 2006 Jan 1;64(1):57-62. doi: 10.1016/j.ijrobp.2005.03.057. Epub 2005 Jun 2.'}, {'pmid': '28738294', 'type': 'RESULT', 'citation': 'Li K, Yang L, Hu QY, Chen XZ, Chen M, Chen Y. Oral Mucosa Dose Parameters Predicting Grade >/=3 Acute Toxicity in Locally Advanced Nasopharyngeal Carcinoma Patients Treated With Concurrent Intensity-Modulated Radiation Therapy and Chemotherapy: An Independent Validation Study Comparing Oral Cavity versus Mucosal Surface Contouring Techniques. Transl Oncol. 2017 Oct;10(5):752-759. doi: 10.1016/j.tranon.2017.06.011. Epub 2017 Jul 21.'}, {'pmid': '34714553', 'type': 'RESULT', 'citation': 'Elad S, Yarom N, Zadik Y, Kuten-Shorrer M, Sonis ST. The broadening scope of oral mucositis and oral ulcerative mucosal toxicities of anticancer therapies. CA Cancer J Clin. 2022 Jan;72(1):57-77. doi: 10.3322/caac.21704. Epub 2021 Oct 29.'}, {'pmid': '34484592', 'type': 'RESULT', 'citation': 'Soutome S, Yanamoto S, Nishii M, Kojima Y, Hasegawa T, Funahara M, Akashi M, Saito T, Umeda M. Risk factors for severe radiation-induced oral mucositis in patients with oral cancer. J Dent Sci. 2021 Oct;16(4):1241-1246. doi: 10.1016/j.jds.2021.01.009. Epub 2021 Feb 9.'}, {'pmid': '33224892', 'type': 'RESULT', 'citation': 'Li PJ, Li KX, Jin T, Lin HM, Fang JB, Yang SY, Shen W, Chen J, Zhang J, Chen XZ, Chen M, Chen YY. Predictive Model and Precaution for Oral Mucositis During Chemo-Radiotherapy in Nasopharyngeal Carcinoma Patients. Front Oncol. 2020 Nov 5;10:596822. doi: 10.3389/fonc.2020.596822. eCollection 2020.'}, {'pmid': '29556480', 'type': 'RESULT', 'citation': 'Gabrys HS, Buettner F, Sterzing F, Hauswald H, Bangert M. Design and Selection of Machine Learning Methods Using Radiomics and Dosiomics for Normal Tissue Complication Probability Modeling of Xerostomia. Front Oncol. 2018 Mar 5;8:35. doi: 10.3389/fonc.2018.00035. eCollection 2018.'}, {'pmid': '28914611', 'type': 'RESULT', 'citation': 'Zhen X, Chen J, Zhong Z, Hrycushko B, Zhou L, Jiang S, Albuquerque K, Gu X. Deep convolutional neural network with transfer learning for rectum toxicity prediction in cervical cancer radiotherapy: a feasibility study. Phys Med Biol. 2017 Oct 12;62(21):8246-8263. doi: 10.1088/1361-6560/aa8d09.'}, {'pmid': '30098025', 'type': 'RESULT', 'citation': 'Ibragimov B, Toesca D, Chang D, Yuan Y, Koong A, Xing L. Development of deep neural network for individualized hepatobiliary toxicity prediction after liver SBRT. Med Phys. 2018 Oct;45(10):4763-4774. doi: 10.1002/mp.13122. Epub 2018 Sep 10.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to apply the CNN-based DL method to extract the three-dimensional spatial information of IMRT dose distribution to predict the occurrence probability of serious radiotherapy and chemotherapy induced oral mucositis(SRCOM), and compare with a model based on dosimetry, NTCP or doseomics to improve the prediction accuracy of SRCOM, thus guiding the clinical planning design, reducing the occurrence probability of OM, and may have the potential value of preventing serious complications and improving the quality of life in patients with nasopharyngeal carcinoma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Primary-treated NPC patients undergoing IMRT', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Initial diagnosis, pathological histological diagnosis, the pathological type is non-keratotic carcinoma (according to the WHO pathological classification).\n* Initial intensity-modulated radiotherapy (Intensity modulated radiation therapy, IMRT).\n* No previous radiotherapy was received.\n\nExclusion Criteria:\n\n* Patients with recurrent nasopharyngeal carcinoma.\n* Radiotherapy plan cannot be obtained.\n* Previous history of malignancy; previous radiotherapy.\n* The primary lesion and cervical metastatic lesions have received surgical treatment (except for diagnostic treatment).'}, 'identificationModule': {'nctId': 'NCT06032767', 'briefTitle': 'Prospective Observational Study to Predict Severe Oral Mucositis Associated With Chemoradiotherapy in Nasopharyngeal Carcinoma Based on Deep Learning', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': 'Prospective Observational Study to Predict Severe Oral Mucositis Associated With Chemoradiotherapy in Nasopharyngeal Carcinoma Based on Deep Learning', 'orgStudyIdInfo': {'id': 'B2022-420-Y01'}}, 'armsInterventionsModule': {'interventions': [{'name': 'observational group', 'type': 'OTHER', 'description': 'patients initially diagnosed with nasopharyngeal carcinoma treated with IMRT'}]}, 'contactsLocationsModule': {'locations': [{'zip': '510060', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Fang-Yun Xie, professor', 'role': 'CONTACT', 'email': 'xiefy@sysucc.org.cn', 'phone': '+86-20-87342926'}], 'facility': 'Sun Yat-sen University Cancer Center', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Fang-Yun Xie, M.D.', 'role': 'CONTACT', 'email': 'xiefy@sysucc.org.cn', 'phone': '+8613902205880'}, {'name': 'Pu-Yun OuYang, M.D.', 'role': 'CONTACT', 'email': 'ouyangpy@sysucc.org.cn', 'phone': '+8618565382769'}], 'overallOfficials': [{'name': 'Fang-Yun Xie, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sun Yat-sen University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Fang-Yun Xie', 'investigatorAffiliation': 'Sun Yat-sen University'}}}}