Ignite Creation Date:
2025-12-24 @ 11:19 PM
Ignite Modification Date:
2025-12-25 @ 8:59 PM
Study NCT ID:
NCT04413656
Status:
UNKNOWN
Last Update Posted:
2020-06-04
First Post:
2019-11-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
cfDNA Methylation Assay for Clinical Evaluation of Patients With Stage IA Lung Cancer After Ablation Operation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}], 'ancestors': [{'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-06-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2021-06-17', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-05-28', 'studyFirstSubmitDate': '2019-11-11', 'studyFirstSubmitQcDate': '2020-05-28', 'lastUpdatePostDateStruct': {'date': '2020-06-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-17', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Screening and monitoring the change of cfDNA methylation index', 'timeFrame': 'before surgery , after surgery 1month, 3month, 6month，9month，12month，18month and 24month', 'description': 'Screening and monitoring the change of cfDNA methylation index in patients with stage I lung cancer after ablation'}], 'secondaryOutcomes': [{'measure': 'Comparing similarities and differences between cfDNA methylation in surgical treatment and ablation', 'timeFrame': 'before surgery , after surgery 1month, 3month', 'description': 'Comparing similarities and differences between cfDNA methylation in surgical treatment and ablation of patients with stage I lung cancer'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ablation', 'circulating free DNA', 'methylation'], 'conditions': ['Lung Cancer']}, 'descriptionModule': {'briefSummary': 'The objective is to screen and monitor the efficacy of cfDNA methylation in patients with stage I lung cancer after ablation, to compare the similarities and differences of cfDNA methylation between surgical treatment and ablation in patients with stage I lung cancer, and to look for new indicators to assess the efficacy of ablation therapy and to monitor lung cancer recurrence.', 'detailedDescription': 'The objective is to screen and monitor the efficacy of cfDNA methylation in patients with stage I lung cancer after ablation, to compare the similarities and differences of cfDNA methylation between surgical treatment and ablation in patients with stage I lung cancer, and to look for new indicators to assess the efficacy of ablation therapy and to monitor lung cancer recurrence.\n\nThe main research content is to screen the cfDNA methylation index that can monitor the efficacy of stage I lung cancer ablation and compare the similarities and differences of cfDNA methylation in patients with stage I lung cancer after surgery and ablation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age: 18-85 years old;\n2. The peripheral pulmonary nodules found in patients with chest CT, preoperative examination showed that the clinical stage of patients was T1N0M0, IA;\n3. patients are not suitable for surgical treatment through multidisciplinary assessment, agree to accept ablation\n4. Patients have good compliance with the tests and follow-ups, understand the situation of the study and sign informed consent.\n\nExclusion Criteria:\n\n1. The patient is generally in poor condition and cannot tolerate the examination;\n2. patients with a cardiac pacemaker or stent in the heart; peripheral tumors of the lungs are adjacent to large blood vessels or important structures;\n3. patients with poor compliance;\n4. Researchers believe that it is not appropriate to participate in this trial.'}, 'identificationModule': {'nctId': 'NCT04413656', 'briefTitle': 'cfDNA Methylation Assay for Clinical Evaluation of Patients With Stage IA Lung Cancer After Ablation Operation', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Chest Hospital'}, 'officialTitle': 'cfDNA Methylation Assay for Clinical Evaluation of Patients With Stage IA Lung Cancer After Ablation Operation', 'orgStudyIdInfo': {'id': 'SHCHE201902'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ablation group', 'description': 'Patients with stage IA inoperable peripheral lung tumor will be performed ablation. cfDNA methylation would be monitored at different times(before surgery , after surgery 1month, 3month, and every 3month in the first year and every 6 months in the second ). Meanwhile, post-treatment response will be evaluated and follow up will be carried out according to the standard procedure.', 'interventionNames': ['Other: ablation']}, {'type': 'EXPERIMENTAL', 'label': 'surgery group', 'description': 'Patients with stage IA operable peripheral lung tumor will be performed surgery. cfDNA methylation would be monitored at different time(before surgery , after surgery 1month, 3month). Post-treatment response will be evaluated and follow up will be carried out according to the standard procedure.', 'interventionNames': ['Other: surgery']}], 'interventions': [{'name': 'ablation', 'type': 'OTHER', 'description': 'Patients with stage IA inoperable peripheral lung tumor will be performed ablation. cfDNA methylation would be monitored at different times(before surgery , after surgery 1month, 3month, and every 3month in the first year and every 6 months in the second ).', 'armGroupLabels': ['ablation group']}, {'name': 'surgery', 'type': 'OTHER', 'description': 'Patients with stage IA inoperable peripheral lung tumor will be performed ablation. cfDNA methylation would be monitored at different times(before surgery, after surgery 1month, 3month).', 'armGroupLabels': ['surgery group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200030', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jiayuan Sun, MD, PhD', 'role': 'CONTACT', 'email': 'jysun1976@163.com', 'phone': '86-021-22200000-1501'}, {'name': 'Jiayuan Sun, MD, PhD', 'role': 'CONTACT', 'email': 'jysun1976@163.com', 'phone': '18017321598'}], 'facility': 'Shanghai Chest Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Chest Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief Physician, Department of Pulmonary Medicine, Director, Department of Respiratory Endoscopy and Interventional Pulmonology', 'investigatorFullName': 'Jiayuan Sun', 'investigatorAffiliation': 'Shanghai Chest Hospital'}}}}