Ignite Creation Date:
2025-12-24 @ 5:10 PM
Ignite Modification Date:
2025-12-28 @ 9:16 AM
Study NCT ID:
NCT05426850
Status:
UNKNOWN
Last Update Posted:
2022-06-22
First Post:
2022-05-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ctDNA-based MRD Assessment in Local Advanced Esophageal Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077277', 'term': 'Esophageal Squamous Cell Carcinoma'}], 'ancestors': [{'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D018307', 'term': 'Neoplasms, Squamous Cell'}, {'id': 'D004938', 'term': 'Esophageal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2024-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-06-16', 'studyFirstSubmitDate': '2022-05-24', 'studyFirstSubmitQcDate': '2022-06-16', 'lastUpdatePostDateStruct': {'date': '2022-06-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Relationship between ctDNA status after chemoradiotherapy and relapse.', 'timeFrame': 'ctDNA will be tested within 1 year after chemoradiotherapy', 'description': 'To assess if recurrent esophageal cancer is detectable earlier by ctDNA positive in plasma.'}], 'secondaryOutcomes': [{'measure': 'Changes of ctDNA status.', 'timeFrame': 'before and at the end of radiotherapy (+1 week); at the end of consolidation chemotherapy (+1 week); at 2 weeks, 1 month, 3 months, 6 months, 9 months, 1 year after dCCRT.', 'description': 'To dynamically evaluate the ctDNA status at baseline, during treatment and follow-up.'}, {'measure': 'Overall survival (OS).', 'timeFrame': 'through study completion, an average of 2 years.', 'description': 'To compare OS in ctDNA(+) patients and ctDNA(-) patients.'}, {'measure': 'Relapse-free survival (RFS) and progression-free survival (PFS).', 'timeFrame': 'through study completion, an average of 2 years.', 'description': 'To compare RFS and PFS in ctDNA(+) patients and ctDNA(-) patients.'}, {'measure': 'Relationships between radiomics features, ctDNA status and relapse.', 'timeFrame': 'through study completion, an average of 2 years.', 'description': 'To assess if recurrent esophageal cancer is detectable earlier by ctDNA positive in plasma compared to traditional radiographic methods.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Esophageal Squamous Cell Carcinoma']}, 'descriptionModule': {'briefSummary': 'To analyze the relationship between the dynamic changes of circulating tumor DNA (ctDNA) and tumor relapse of esophageal squamous cell carcinoma treated by concurrent chemoradiotherapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Local advanced esophageal squamous cell carcinoma treated by definitive concurrent chemoradiotherapy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. 18-75 years old.\n2. ECOG 0-1.\n3. Esophageal squamous cell carcinoma confirmed by pathology.\n4. No radiotherapy, chemotherapy, or other treatments prior to enrollment.\n5. Locally advanced esophageal squamous cell carcinoma (II-IVa, IVB with supraclavicular lymph node metastasis).\n6. No severe abnormal hematopoietic, cardiac, pulmonary, renal, hepatic function, or immunodeficiency.\n7. Informed consent signed.\n\nExclusion Criteria:\n\n1. Less than 50.4Gy/28fx of radiotherapy dose.\n2. Without Concurrent chemotherapy.\n3. Pregnant or breastfeeding women or fertile patients who refused to use contraceptives.'}, 'identificationModule': {'nctId': 'NCT05426850', 'briefTitle': 'ctDNA-based MRD Assessment in Local Advanced Esophageal Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Fudan University'}, 'officialTitle': 'Circulating Tumor DNA-based Minimal Residual Disease (MRD) Assessment in Local Advanced Esophageal Squamous Cell Carcinoma Treated by Definitive Concurrent Chemoradiotherapy', 'orgStudyIdInfo': {'id': 'ESO-Shanghai16'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'ctDNA(+) Cohort', 'description': 'ctDNA(+) Cohort in pretreatment and posttreatment plasma samples was defined by accessing the presence of one or more mutations identified in match tumor samples.'}, {'label': 'ctDNA(-) Cohort', 'description': 'ctDNA(-) Cohort in pretreatment and posttreatment plasma samples was defined by the absence of one or more mutations identified in match tumor samples.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '200032', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Kuaile Zhao, M.D.', 'role': 'CONTACT', 'email': 'kuaile_z@sina.com', 'phone': '86-18017312534'}], 'facility': 'Fudan University Shanghai cancer center', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fudan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Kuai Le Zhao, MD', 'investigatorAffiliation': 'Fudan University'}}}}