Ignite Creation Date:
2025-12-24 @ 11:36 PM
Ignite Modification Date:
2026-01-01 @ 7:48 AM
Study NCT ID:
NCT04905056
Status:
RECRUITING
Last Update Posted:
2021-05-27
First Post:
2021-05-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Prospective, Two-center, Single Arm Phase II Clinical Study to Evaluate Safety and Effectiveness of Ablation Therapy in the Treatment of Lung Cancer Presenting as Ground-glass Nodules
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018450', 'term': 'Disease Progression'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-05-23', 'studyFirstSubmitDate': '2021-05-23', 'studyFirstSubmitQcDate': '2021-05-23', 'lastUpdatePostDateStruct': {'date': '2021-05-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'progression free survival', 'timeFrame': '1 years', 'description': 'One year progression free survival after radiofrequency ablation of ground glass nodules'}], 'secondaryOutcomes': [{'measure': 'overall survival', 'timeFrame': '1 years, 3 years, 5years', 'description': 'overall survival after radiofrequency ablation of ground glass nodules'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Progression']}, 'descriptionModule': {'briefSummary': 'A prospective, two-center, single arm phase II clinical study to evaluate safety and effectiveness of ablation therapy in the treatment of lung cancer presenting as ground-glass nodules'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Aged between 18 and 85 years;\n2. GGO is diagnosed by lung CT and failure to subside after 3 months (the patient having been re-examined by thin-section CT);\n3. The maximum diameter of the GGO is bigger than 8mm and smaller than 3cm;\n4. For single GGO: obvious progress was observed in pure GGO or the solid component of mixed ground glass nodules was more than or equal to 2 mm\n5. The patients were unable to tolerate the operation for various reasons or multiple grinding glass nodules, operation can not be completely removed; or patients had received surgery in ipsilateral chest\n6. The patient is able to understand and comply with the study and has provided written informed consent\n\nExclusion Criteria:\n\n1. Patients who participated in any drug and / or medical device clinical trials within one month before the trial\n2. had severe disease conditions\n3. allergy to narcotic drugs\n4. had other autoimmune disease\n5. dementia or cognitive impairment can't cooperate with researchers\n6. any local treatment other than ablation was received within 4 weeks before the study"}, 'identificationModule': {'nctId': 'NCT04905056', 'briefTitle': 'A Prospective, Two-center, Single Arm Phase II Clinical Study to Evaluate Safety and Effectiveness of Ablation Therapy in the Treatment of Lung Cancer Presenting as Ground-glass Nodules', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Zhongshan Hospital'}, 'officialTitle': 'A Prospective, Two-center, Single Arm Phase II Clinical Study to Evaluate Safety and Effectiveness of Ablation Therapy in the Treatment of Lung Cancer Presenting as Ground-glass Nodules', 'orgStudyIdInfo': {'id': 'B2021-088R'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ablation therapy in the treatment of lung cancer presenting as ground-glass nodules', 'interventionNames': ['Other: Ablation therapy']}], 'interventions': [{'name': 'Ablation therapy', 'type': 'OTHER', 'description': 'Ablation therapy in the treatment of lung cancer presenting as ground-glass nodules', 'armGroupLabels': ['ablation therapy in the treatment of lung cancer presenting as ground-glass nodules']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200032', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Qun Wang, phd', 'role': 'CONTACT', 'email': '13301050210@fudan.edu.cn', 'phone': '86-21-64041990'}], 'facility': 'Department of Thoracic Surgery, Zhongshan Hospital, Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Qun Wang, Phd', 'role': 'CONTACT', 'email': '13301050210@fudan.edu.cn', 'phone': '86-21-64041990'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Zhongshan Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Xi Junjie', 'investigatorAffiliation': 'Shanghai Zhongshan Hospital'}}}}