Ignite Creation Date:
2025-12-24 @ 1:51 PM
Ignite Modification Date:
2025-12-30 @ 3:53 AM
Study NCT ID:
NCT06979895
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-05-20
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 Gastric Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013274', 'term': 'Stomach Neoplasms'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-05-25', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2030-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-18', 'studyFirstSubmitDate': '2025-04-23', 'studyFirstSubmitQcDate': '2025-05-18', 'lastUpdatePostDateStruct': {'date': '2025-05-20', 'type': 'ACTUAL'}, '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'}], '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gastric (Stomach) 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': 'Gastric cancer patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAge at initial diagnosis: 18-75 years Histologically confirmed gastric or gastroesophageal junction malignancy, with complete medical records, confirmed pathological diagnosis, and definitive staging data (TNM staging system) No history of other primary malignancies Absence of distant metastases (liver, lung, or other sites) confirmed by imaging examination (CT/MRI) No prior surgical resection, chemotherapy, or PD-1/PD-L1 immunotherapy before enrollment Availability of complete biospecimen information, including: Sample ID (medical record number), Demographic data (sex, age), Clinical diagnostic data, Tumor marker profiles (CEA, CA19-9, etc.)\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': 'NCT06979895', 'briefTitle': 'Investigating Multigene Methylation Dynamics in Treatment Response Surveillance for Gastric Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Xijing Hospital'}, 'officialTitle': 'Investigating Multigene Methylation Dynamics in Treatment Response Surveillance for Gastric Cancer', 'orgStudyIdInfo': {'id': 'KY20252141-F-1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group one', 'description': 'Gastric cancer patients undergoing primary surgical treatment', 'interventionNames': ['Other: Multi-gene methylation testing']}, {'label': 'Group two', 'description': 'Gastric cancer patients undergoing surgery following neoadjuvant therapy', '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']}]}, 'contactsLocationsModule': {'locations': [{'city': "Xi'an", 'state': 'Shaanxi', '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', '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}}], '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'}}}}