Ignite Creation Date:
2025-12-24 @ 11:10 PM
Ignite Modification Date:
2026-01-01 @ 1:55 PM
Study NCT ID:
NCT06979869
Status:
RECRUITING
Last Update Posted:
2025-12-16
First Post:
2025-04-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigating Multigene Methylation Dynamics in Treatment Response Surveillance for Esophageal Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004938', 'term': 'Esophageal Neoplasms'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'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': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-05-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2030-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-14', 'studyFirstSubmitDate': '2025-04-23', 'studyFirstSubmitQcDate': '2025-05-18', 'lastUpdatePostDateStruct': {'date': '2025-12-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-05-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Multi-gene methylation levels', 'timeFrame': 'Group one: Preoperative, 1 week, 1 month, 3 months, 6 months, 1 year, 1.5 years, 2 years, 3 years, 4 years, and 5 years postoperatively.'}, {'measure': 'Multi-gene methylation levels', 'timeFrame': 'Group two: pre-neoadjuvant therapy baseline, 1 week following neoadjuvant therapy, and postoperatively at 1 week, 1 month, 3 months, 6 months, 1 year, 18 months (1.5 years), 2 years, 3 years, 4 years, and 5 years.'}, {'measure': 'Multi-gene methylation levels', 'timeFrame': 'Group three: pre-neoadjuvant therapy baseline, 1 week following neoadjuvant therapy, and post-neoadjuvant therapy at 1 month, 3 months, 6 months, 1 year, 18 months (1.5 years), 2 years, 3 years, 4 years, and 5 years.'}, {'measure': 'Multi-gene methylation levels', 'timeFrame': 'Group four: pre-definitive chemoradiotherapy baseline, and post-definitive chemoradiotherapy at 1 month, 3 months, 6 months, 1 year, 18 months (1.5 years), 2 years, 3 years, 4 years, and 5 years.'}], 'secondaryOutcomes': [{'measure': 'Tumor Markers (including CEA, AFP, CA125, CA19-9, CA72-4, etc.)', 'timeFrame': 'Group one: Preoperative, 1 week, 1 month, 3 months, 6 months, 1 year, 1.5 years, 2 years, 3 years, 4 years, and 5 years postoperatively.', 'description': 'Tumor Markers (including CEA, AFP, CA125, CA19-9, CA72-4, etc.) results will be extracted from historical medical records, with test dates typically ranging from baseline (within 3 months pre-enrollment) to follow-up intervals aligned with standard clinical practice (e.g., every 3-6 months post-treatment). These time points may not synchronize with the methylation assessment schedule.'}, {'measure': 'Imaging Examinations (including contrast-enhanced CT, PET/CT, ultrasound, X-ray, magnetic resonance imaging, etc.)', 'timeFrame': 'Group one: Preoperative, 1 week, 1 month, 3 months, 6 months, 1 year, 1.5 years, 2 years, 3 years, 4 years, and 5 years postoperatively.', 'description': 'Imaging examinations (including contrast-enhanced CT, PET/CT, ultrasound, X-ray, magnetic resonance imaging, etc.) results will be collected from patient records. Imaging time points are determined by clinical needs (e.g., pre-treatment staging, 3-month post-treatment follow-up), with intervals independent of the methylation analysis schedule. The minimum interval between imaging and methylation sampling will be recorded.'}, {'measure': 'Endoscope', 'timeFrame': 'Group one: Preoperative, 1 week, 1 month, 3 months, 6 months, 1 year, 1.5 years, 2 years, 3 years, 4 years, and 5 years postoperatively.', 'description': 'Endoscoping results will be collected from patient records. Imaging time points are determined by clinical needs (e.g., pre-treatment staging, 3-month post-treatment follow-up), with intervals independent of the methylation analysis schedule. The minimum interval between imaging and methylation sampling will be recorded.'}, {'measure': 'Tumor Markers (including CEA, AFP, CA125, CA19-9, CA72-4, etc.)', 'timeFrame': 'Group two: pre-neoadjuvant therapy baseline, 1 week following neoadjuvant therapy, and postoperatively at 1 week, 1 month, 3 months, 6 months, 1 year, 18 months (1.5 years), 2 years, 3 years, 4 years, and 5 years.', 'description': 'Tumor Markers (including CEA, AFP, CA125, CA19-9, CA72-4, etc.) results will be extracted from historical medical records, with test dates typically ranging from baseline (within 3 months pre-enrollment) to follow-up intervals aligned with standard clinical practice (e.g., every 3-6 months post-treatment). These time points may not synchronize with the methylation assessment schedule.'}, {'measure': 'Imaging Examinations (including contrast-enhanced CT, PET/CT, ultrasound, X-ray, magnetic resonance imaging, etc.)', 'timeFrame': 'Group two: pre-neoadjuvant therapy baseline, 1 week following neoadjuvant therapy, and postoperatively at 1 week, 1 month, 3 months, 6 months, 1 year, 18 months (1.5 years), 2 years, 3 years, 4 years, and 5 years.', 'description': 'Imaging examinations (including contrast-enhanced CT, PET/CT, ultrasound, X-ray, magnetic resonance imaging, etc.) results will be collected from patient records. Imaging time points are determined by clinical needs (e.g., pre-treatment staging, 3-month post-treatment follow-up), with intervals independent of the methylation analysis schedule. The minimum interval between imaging and methylation sampling will be recorded.'}, {'measure': 'Endoscope', 'timeFrame': 'Group two: pre-neoadjuvant therapy baseline, 1 week following neoadjuvant therapy, and postoperatively at 1 week, 1 month, 3 months, 6 months, 1 year, 18 months (1.5 years), 2 years, 3 years, 4 years, and 5 years.', 'description': 'Endoscoping results will be collected from patient records. Imaging time points are determined by clinical needs (e.g., pre-treatment staging, 3-month post-treatment follow-up), with intervals independent of the methylation analysis schedule. The minimum interval between imaging and methylation sampling will be recorded.'}, {'measure': 'Tumor Markers (including CEA, AFP, CA125, CA19-9, CA72-4, etc.)', 'timeFrame': 'Group three: pre-neoadjuvant therapy baseline, 1 week following neoadjuvant therapy, and post-neoadjuvant therapy at 1 month, 3 months, 6 months, 1 year, 18 months (1.5 years), 2 years, 3 years, 4 years, and 5 years.', 'description': 'Tumor Markers (including CEA, AFP, CA125, CA19-9, CA72-4, etc.) results will be extracted from historical medical records, with test dates typically ranging from baseline (within 3 months pre-enrollment) to follow-up intervals aligned with standard clinical practice (e.g., every 3-6 months post-treatment). These time points may not synchronize with the methylation assessment schedule.'}, {'measure': 'Imaging Examinations (including contrast-enhanced CT, PET/CT, ultrasound, X-ray, magnetic resonance imaging, etc.)', 'timeFrame': 'Group three: pre-neoadjuvant therapy baseline, 1 week following neoadjuvant therapy, and post-neoadjuvant therapy at 1 month, 3 months, 6 months, 1 year, 18 months (1.5 years), 2 years, 3 years, 4 years, and 5 years.', 'description': 'Imaging examinations (including contrast-enhanced CT, PET/CT, ultrasound, X-ray, magnetic resonance imaging, etc.) results will be collected from patient records. Imaging time points are determined by clinical needs (e.g., pre-treatment staging, 3-month post-treatment follow-up), with intervals independent of the methylation analysis schedule. The minimum interval between imaging and methylation sampling will be recorded.'}, {'measure': 'Endoscope', 'timeFrame': 'Group three: pre-neoadjuvant therapy baseline, 1 week following neoadjuvant therapy, and post-neoadjuvant therapy at 1 month, 3 months, 6 months, 1 year, 18 months (1.5 years), 2 years, 3 years, 4 years, and 5 years.', 'description': 'Endoscoping results will be collected from patient records. Imaging time points are determined by clinical needs (e.g., pre-treatment staging, 3-month post-treatment follow-up), with intervals independent of the methylation analysis schedule. The minimum interval between imaging and methylation sampling will be recorded.'}, {'measure': 'Tumor Markers (including CEA, AFP, CA125, CA19-9, CA72-4, etc.)', 'timeFrame': 'Group four: pre-definitive chemoradiotherapy baseline, and post-definitive chemoradiotherapy at 1 month, 3 months, 6 months, 1 year, 18 months (1.5 years), 2 years, 3 years, 4 years, and 5 years.', 'description': 'Tumor Markers (including CEA, AFP, CA125, CA19-9, CA72-4, etc.) results will be extracted from historical medical records, with test dates typically ranging from baseline (within 3 months pre-enrollment) to follow-up intervals aligned with standard clinical practice (e.g., every 3-6 months post-treatment). These time points may not synchronize with the methylation assessment schedule.'}, {'measure': 'Imaging Examinations (including contrast-enhanced CT, PET/CT, ultrasound, X-ray, magnetic resonance imaging, etc.)', 'timeFrame': 'Group four: pre-definitive chemoradiotherapy baseline, and post-definitive chemoradiotherapy at 1 month, 3 months, 6 months, 1 year, 18 months (1.5 years), 2 years, 3 years, 4 years, and 5 years.', 'description': 'Imaging examinations (including contrast-enhanced CT, PET/CT, ultrasound, X-ray, magnetic resonance imaging, etc.) results will be collected from patient records. Imaging time points are determined by clinical needs (e.g., pre-treatment staging, 3-month post-treatment follow-up), with intervals independent of the methylation analysis schedule. The minimum interval between imaging and methylation sampling will be recorded.'}, {'measure': 'Endoscope', 'timeFrame': 'Group four: pre-definitive chemoradiotherapy baseline, and post-definitive chemoradiotherapy at 1 month, 3 months, 6 months, 1 year, 18 months (1.5 years), 2 years, 3 years, 4 years, and 5 years.', 'description': 'Endoscoping results will be collected from patient records. Imaging time points are determined by clinical needs (e.g., pre-treatment staging, 3-month post-treatment follow-up), with intervals independent of the methylation analysis schedule. The minimum interval between imaging and methylation sampling will be recorded.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Esophageal Cancer']}, 'descriptionModule': {'briefSummary': 'The primary objective is to determine whether pretreatment-to-posttreatment changes in circulating multigene methylation levels correlate with objective response rates (ORR) assessed by contrast-enhanced CT/MRI and levels of serum tumor markers. Secondary endpoints include: (a) time-dependent association between methylation fluctuation patterns and progression-free survival (PFS), (b) comparative diagnostic accuracy of methylation indices versus conventional biomarkers, and (c) feasibility of using methylation thresholds to guide adaptive therapy modification.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Esophageal cancer patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAge at initial diagnosis: 18-75 years (inclusive) Confirmed diagnosis: Histologically proven esophageal carcinoma with complete medical records, including (a) definitive pathological diagnosis report, (b) TNM staging per AJCC 8th edition criteria Cancer history: No prior malignancies at other anatomical sites (excluding cured non-melanoma skin cancers/carcinoma in situ) Metastasis status: Radiologically confirmed absence of distant metastases in liver, lungs, or other organs via contrast-enhanced CT/MRI and whole-body bone scan within 4 weeks before enrollment Treatment-naïve status: No previous exposure to (i) esophageal resection surgery, (ii) systemic chemotherapy, (iii) thoracic radiation therapy (\\>10 Gy), or (iv) PD-1/PD-L1 immune checkpoint inhibitors\n\nExclusion Criteria:\n\nLife expectancy \\<6 months (as assessed by ECOG score ≥4 or Palliative Performance Scale ≤30%) Cognitive/psychiatric conditions: a. Legally incapacitated individuals without legal guardians, b. Active psychotic disorders (e.g., schizophrenia, bipolar disorder) or dementia (MMSE score \\<24) Investigator-determined exclusions'}, 'identificationModule': {'nctId': 'NCT06979869', 'briefTitle': 'Investigating Multigene Methylation Dynamics in Treatment Response Surveillance for Esophageal Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Xijing Hospital'}, 'officialTitle': 'Investigating Multigene Methylation Dynamics in Treatment Response Surveillance for Esophageal Carcinoma', 'orgStudyIdInfo': {'id': 'KY20252117-F-1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group one', 'description': 'Esophageal cancer patients undergoing primary surgical treatment', 'interventionNames': ['Other: Multi-gene methylation testing']}, {'label': 'Group two', 'description': 'Esophageal cancer patients undergoing surgery following neoadjuvant therapy', 'interventionNames': ['Other: Multi-gene methylation testing']}, {'label': 'Group three', 'description': 'Esophageal cancer patients undergoing active surveillance following neoadjuvant therapy', 'interventionNames': ['Other: Multi-gene methylation testing']}, {'label': 'Group four', 'description': 'Esophageal cancer patients undergoing definitive chemoradiotherapy with or without immunotherapy', 'interventionNames': ['Other: Multi-gene methylation testing']}], 'interventions': [{'name': 'Multi-gene methylation testing', 'type': 'OTHER', 'description': 'Undergo multi-gene methylation testing in blood during follow-up', 'armGroupLabels': ['Group one']}, {'name': 'Multi-gene methylation testing', 'type': 'OTHER', 'description': 'Undergo multi-gene methylation testing in blood during follow-up', 'armGroupLabels': ['Group two']}, {'name': 'Multi-gene methylation testing', 'type': 'OTHER', 'description': 'Undergo multi-gene methylation testing in blood during follow-up', 'armGroupLabels': ['Group three']}, {'name': 'Multi-gene methylation testing', 'type': 'OTHER', 'description': 'Undergo multi-gene methylation testing in blood during follow-up', 'armGroupLabels': ['Group four']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Wuwei', 'state': 'Gansu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Sitian Dai', 'role': 'CONTACT', 'email': 'dai15075843463@163.com', 'phone': '+86 19567636380'}], 'facility': 'Gansu Wuwei Cancer Hospital', 'geoPoint': {'lat': 37.92672, 'lon': 102.63202}}, {'city': 'Shantou', 'state': 'Guangdong', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jialu Jiang', 'role': 'CONTACT', 'email': 'jiangjialu325@163.com', 'phone': '+86 18354692937'}], 'facility': 'Cancer Hospital Affiliated to Shantou University Medical College', 'geoPoint': {'lat': 23.35489, 'lon': 116.67876}}, {'city': 'Zhaoqing', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xianchun Gao', 'role': 'CONTACT', 'email': 'gigaoxc@163.com', 'phone': '+86 18165302960'}], 'facility': "Zhaoqing Gaoyao District People's Hospital", 'geoPoint': {'lat': 23.04893, 'lon': 112.46091}}, {'city': 'Zhengzhou', 'state': 'Henan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Abudurousuli Reyila', 'role': 'CONTACT', 'email': 'ryldoct@163.com', 'phone': '+86 15254166320'}], 'facility': 'Henan Cancer Hospital', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}, {'city': "Xi'an", 'state': 'Shaanxi', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xianchun Gao, doctor', 'role': 'CONTACT', 'email': 'gigaoxc@163.com', 'phone': '+86 18165302960'}], 'facility': 'Tangdu Hospital', 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}, {'city': "Xi'an", 'state': 'Shaanxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhongyang Zhang', 'role': 'CONTACT', 'email': '18831363219@163.com', 'phone': '+86 188 3136 3219'}], 'facility': 'Xijing Hospital', 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}, {'city': 'Yan’an', 'state': 'Shaanxi', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jun Yu', 'role': 'CONTACT', 'email': 'drxiaoyu0801@163.com', 'phone': '+86 15872427852'}], 'facility': "The First Affiliated Hospital of Yan'an University", 'geoPoint': {'lat': 36.59889, 'lon': 109.49167}}, {'city': 'Taiyuan', 'state': 'Shanxi', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yan Pan', 'role': 'CONTACT', 'email': 'panpan@fmmu.edu.cn', 'phone': '+86 13484660214'}], 'facility': 'The First Affiliated Hospital of Shanxi Medical University', 'geoPoint': {'lat': 37.86944, 'lon': 112.56028}}, {'city': 'Chengdu', 'state': 'Sichuan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Rong Zheng', 'role': 'CONTACT', 'email': 'zhengrong4956@163.com', 'phone': '19829758242'}], 'facility': "General Hospital of Western Theater Command, People's Liberation Army (PLA)", 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}], 'centralContacts': [{'name': 'Zhongyang Zhang', 'role': 'CONTACT', 'email': '18831363219@163.com', 'phone': '+86 188 3136 3219'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xijing Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}