Ignite Creation Date:
2025-12-24 @ 7:24 PM
Ignite Modification Date:
2025-12-26 @ 3:50 PM
Study NCT ID:
NCT05448703
Status:
RECRUITING
Last Update Posted:
2022-10-06
First Post:
2022-07-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study on Predictive Models and Clinical Outcome of Radiation Pneumonitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017564', 'term': 'Radiation Pneumonitis'}], 'ancestors': [{'id': 'D017563', 'term': 'Lung Diseases, Interstitial'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D055370', 'term': 'Lung Injury'}, {'id': 'D011832', 'term': 'Radiation Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}, {'id': 'D015415', 'term': 'Biomarkers'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'From peripheral blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-02-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2026-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-10-05', 'studyFirstSubmitDate': '2022-07-01', 'studyFirstSubmitQcDate': '2022-07-02', 'lastUpdatePostDateStruct': {'date': '2022-10-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Radiation pneumonitis', 'timeFrame': '12 months after radiotherapy', 'description': 'radiation pneumonitis grade \\>=2 or 3 graded by CTCAE4.0. \\[Time Frame: 12 months after radiotherapy\\]'}, {'measure': 'Overall Survival', 'timeFrame': '5 years after radiotherapy', 'description': 'A long-term follow up will be scheduled to allow a complete survival analysis.'}], 'secondaryOutcomes': [{'measure': 'Other injuries induced by radiotherapy', 'timeFrame': '5 years after radiotherapy', 'description': 'Assessment of other common injuries induced by thoracic radiotherapy including injuries in heart, skin, and esophagus according to CTCAE4.0.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Radiation Pneumonitis']}, 'descriptionModule': {'briefSummary': 'Radiation pneumonitis is the main dose-limiting toxicity of thoracic radiotherapy, which can affect life quality, survival, and the tumor-controlling effects of patients receiving thoracic radiotherapy.\n\nThe purpose of this study is to:\n\n* Identify biomarkers including serum proteins, gene expression, genetic changes, and epigenetic modifications that determine radiation pneumonitis.\n* Investigate the relationship between radiation pneumonitis and other toxicities induced by radiotherapy.\n* Construct a predictive model for radiation pneumonitis.\n* Evaluate survival and treatment outcome of patients with radiation pneumonitis.', 'detailedDescription': "1. Collect clinical information, CT images, and peripheral blood of the lung cancer patients treated with thoracic radiotherapy in Tongji Hospital, Hubei Cancer Hospital, and Jingjiang People's Hospital.\n2. Follow up the enrolled patients. All patients enrolled in this study are examined during and one month after radiotherapy. Then, the patients are followed every three months for the first year and every six months thereafter. At each follow-up visits, all patients are asked to undergo a chest CT, and information including survival status, symptoms, CT images, and treatment is collected. Radiation pneumonitis and other toxicities induced by radiotherapy are graded by two radiation oncologists according to the Common Terminology Criteria for Adverse Events 4.0 (CTCAE4.0).\n3. Detect serum proteins, gene expression profile, single-nucleotide polymorphisms, and epigenetic modifications that may be associated with radiation pneumonitis.\n4. Screen biomarkers that are associated with radiation pneumonitis via univariate and multivariate Cox regression analysis.\n5. Construct a predictive model of radiation pneumonitis based on clinical information, radiomics, and biomarkers via machine learning or Least absolute shrinkage and selection operator.\n6. Use Kaplan-Meier and Cox model to analyze the association of radiation pneumonitis with survival and efficacy of antitumor treatment.\n7. Identify biomarkers and predictors of other toxicities induced by radiotherapy including radiation esophagitis, cardiotoxicity and radiodermatitis."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Lung cancer patients treated with thoracic radiotherapy.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Clinical diagnosis of lung cancer by histology\n2. Radiation dose at least 45 Gy\n3. Karnofsky \\>60\n4. Age\\>18\n5. Life expectancy of at least 6 months\n\nExclusion Criteria:\n\n1. Previous thoracic irradiation\n2. Severe cardiopulmonary diseases'}, 'identificationModule': {'nctId': 'NCT05448703', 'briefTitle': 'A Study on Predictive Models and Clinical Outcome of Radiation Pneumonitis', 'organization': {'class': 'OTHER', 'fullName': 'Huazhong University of Science and Technology'}, 'officialTitle': 'A Multicenter Prospective Observational Study on Predictive Models and Clinical Outcome of Radiation Pneumonitis', 'orgStudyIdInfo': {'id': 'TJCC012'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1', 'description': 'Lung cancer patients treated with thoracic radiotherapy', 'interventionNames': ['Other: Blood Samples for Biomarkers']}], 'interventions': [{'name': 'Blood Samples for Biomarkers', 'type': 'OTHER', 'description': 'blood sample to be taken at baseline, during radiotherapy, and after radiotherapy', 'armGroupLabels': ['Group 1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43000', 'city': 'Wuhan', 'state': 'Hubei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Guang Han, PhD', 'role': 'CONTACT', 'email': 'hg7913@hotmail.com', 'phone': '+8613886048178'}, {'name': 'Ying Li, MD', 'role': 'CONTACT', 'email': 'hbwhw08@163.com', 'phone': '+8613628635363'}], 'facility': 'Hubei Cancer Hospital, Tongji Medical College, Huazhong University of Science and Technology', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'zip': '430030', 'city': 'Wuhan', 'state': 'Hubei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xianglin Yuan, PhD', 'role': 'CONTACT', 'email': 'yuanxianglin@hust.edu.cn', 'phone': '+8613667241722'}, {'name': 'Lingyan Xiao, MD', 'role': 'CONTACT', 'email': 'lingyan.xiao123@gmail.com', 'phone': '+8615971474885'}, {'name': 'Xianglin Xianglin, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'zip': '214500', 'city': 'Jingjiang', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Dewen Wang, Bachelor', 'role': 'CONTACT', 'email': 'jsjjwdw@163.com', 'phone': '+8613815985599'}, {'name': 'Lihua Fan, MD', 'role': 'CONTACT', 'email': '980692748@qq.com', 'phone': '+8613852619599'}], 'facility': "Jingjiang People' Hospital", 'geoPoint': {'lat': 32.01417, 'lon': 120.2625}}], 'centralContacts': [{'name': 'Xianglin Yuan, PhD', 'role': 'CONTACT', 'email': 'yuanxianglin@hust.edu.cn', 'phone': '+8613667241722'}, {'name': 'Lingyan Xiao, MD', 'role': 'CONTACT', 'email': 'lingyan.xiao123@gmail.com', 'phone': '+8615971474885'}], 'overallOfficials': [{'name': 'Xianglin Yuan, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tongji Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Huazhong University of Science and Technology', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hubei Cancer Hospital, Tongji Medical College, Huazhong University of Science and Technology', 'class': 'UNKNOWN'}, {'name': "Jingjiang People' Hospital", 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, Chief Physician', 'investigatorFullName': 'Xianglin Yuan', 'investigatorAffiliation': 'Huazhong University of Science and Technology'}}}}