Ignite Creation Date:
2025-12-24 @ 11:51 PM
Ignite Modification Date:
2025-12-28 @ 2:49 AM
Study NCT ID:
NCT05219851
Status:
RECRUITING
Last Update Posted:
2024-03-15
First Post:
2022-01-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Risk Factors for Acute Radiation Pneumonitis in Patients With Prior Receipt of Immune Checkpoint Inhibitors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011014', 'term': 'Pneumonia'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 250}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2025-10-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-13', 'studyFirstSubmitDate': '2022-01-21', 'studyFirstSubmitQcDate': '2022-02-01', 'lastUpdatePostDateStruct': {'date': '2024-03-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of acute radiation pneumonitis (aRPs) in patients with prior receipt of immune checkpoint inhibitors.', 'timeFrame': '6 months after last-patient- radiation', 'description': 'All suspected diagnoses of pneumonitis (regardless of grade) were centrally reviewed by a multidisciplinary committee consisting of at least one radiologist, pulmonologist, and oncologist. CT (or PET-CT) imaging was reviewed for each patient, which was then compared to the radiation treatment plan; other causes such as infection or tumor progression had to be ruled out using the appropriate workup.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['IMRT', 'Radiotherapy', 'Immune checkpoint inhibitor', 'Pneumonitis', 'Risk factors'], 'conditions': ['Cancer Patients']}, 'descriptionModule': {'briefSummary': 'The purpose of this non-interventional study is to collect data on the risk factors for acute radiation pneumonitis in patients with prior receipt of immune checkpoint inhibitors.', 'detailedDescription': '1. Incidence of acute radiation pneumonitis (aRPs) in in patients with prior receipt of immune checkpoint inhibitors.\n2. Risk factors (especially analysis of the dosimetric risk factor) which may affect the product of aRPs events.\n3. Establish a model to predict aRPs and guide clinical treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients treated with the product will be enrolled in the investigation', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Pathologically or cytologically confirmed malignant tumor\n2. Cancer patients with previously received ICIs underwent thoracic intensity-modulated radiotherapy\n\nExclusion Criteria:\n\n1. Cancer patients did not receive immunotherapy before thoracic intensity-modulated radiotherapy\n2. Non-thoracic radiotherapy patients'}, 'identificationModule': {'nctId': 'NCT05219851', 'briefTitle': 'The Risk Factors for Acute Radiation Pneumonitis in Patients With Prior Receipt of Immune Checkpoint Inhibitors', 'organization': {'class': 'OTHER', 'fullName': 'Hubei Cancer Hospital'}, 'officialTitle': 'The Risk Factors for Acute Radiation Pneumonitis in Patients With Prior Receipt of Immune Checkpoint Inhibitors.in Real-world Clinical Practice: a Multicenter, Prospective, Open, Non-interventional Study', 'orgStudyIdInfo': {'id': 'HBCH-RT-2022-RP'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Cancer patients underwent thoracic intensity-modulated radiotherapy', 'type': 'RADIATION', 'description': 'Cancer patients underwent thoracic intensity-modulated radiotherapy, previously received ICIs'}]}, 'contactsLocationsModule': {'locations': [{'zip': '430079', 'city': 'Wuhan', 'state': 'Hubei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Guang Han, MD.Phd', 'role': 'CONTACT', 'phone': '13886048178'}], 'facility': 'Hubei Cancer Hospital', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}], 'centralContacts': [{'name': 'Guang Han, MD.;Ph.D', 'role': 'CONTACT', 'email': 'hg7913@hotmail.com', 'phone': '13886048178'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hubei Cancer Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'HAN GUANG', 'investigatorAffiliation': 'Hubei Cancer Hospital'}}}}