Ignite Creation Date:
2025-12-24 @ 1:20 PM
Ignite Modification Date:
2025-12-30 @ 2:52 AM
Study NCT ID:
NCT06232395
Status:
RECRUITING
Last Update Posted:
2025-06-06
First Post:
2024-01-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Early Detection and Post-operative Monitoring of 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D061809', 'term': 'Human Papillomavirus DNA Tests'}], 'ancestors': [{'id': 'D025202', 'term': 'Molecular Diagnostic Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D005821', 'term': 'Genetic Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Peripheral blood samples collected from each study participant.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1197}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-02-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-02-17', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-03', 'studyFirstSubmitDate': '2024-01-17', 'studyFirstSubmitQcDate': '2024-01-28', 'lastUpdatePostDateStruct': {'date': '2025-06-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02-17', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The performance of the new detection system for gastric cancer (GC) detection', 'timeFrame': '2 years', 'description': 'Evaluate sensitivity, specificity, accuracy, ROC curve area, positive predictive value, and negative predictive value of the new biomarker for the diagnosis of gastric cancer.'}, {'measure': 'The performance of the new biomarkers in the post-operative monitoring of gastric cancer', 'timeFrame': '2 years', 'description': 'Determine whether the new detection system can detect tumor recurrence and metastasis earlier than imaging and tumor marker CA19-9, CEA, and CA72-4.'}], 'secondaryOutcomes': [{'measure': 'Compare the performance of the new biomarkers for GC detection with the conventional tumor markers', 'timeFrame': '2 years', 'description': 'Determine whether the performance of the new biomarker detection system is better than that of tumor markers CA19-9, CEA, and CA72-4 in the diagnosis of gastric cancer.'}, {'measure': 'The performance of the new biomarkers as prognostic biomarkers', 'timeFrame': '2 years', 'description': 'Determine whether the new biomarkers cancer serve as prognostic biomarkers to predict tumor recurrence and metastasis.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gastric Cancer']}, 'descriptionModule': {'briefSummary': 'This study is to determine the performance of non-invasive new multi-target biomarkers in the early detection and post-operative monitoring of gastric cancer.', 'detailedDescription': 'This study aims to develop and validate a new non-invasive detection method for early detection and postoperative monitoring of gastric cancer in the blood. Sensitivity, specificity, accuracy, ROC curve area, positive predictive value, and negative predictive value of the new biomarkers in the diagnosis of gastric cancer will be compared with that of tumor biomarkers CA19-9, CEA, and CA72-4. Blood will also be collected at various time points post-operatively. The investigators will determine whether these new biomarkers can be used as prognostic biomarkers to predict tumor recurrence and metastasis. The investigators will also determine whether these new biomarkers detect tumor recurrence and metastasis earlier than methods currently used in the clinic such as imaging and tumor biomarkers CA19-9, CEA, and CA72-4.\n\nThis study is a prospective and multi-center study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects age over 18, regardless of gender or region, and those who meet the inclusion criteria for this clinical trial, are eligible to enroll at the designated clinical sites. More than 1197subjects are targeted to enroll.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subject age over 18.\n2. Subject has stomach discomfort, and seek medical attention at the Gastric Surgery Department of our center.\n3. Subject has or will have gastroscopy and/or pathological examination results at this center.\n4. Subject must be able to fully understand the informed consent form and be able to personally sign it.\n\nExclusion Criteria:\n\n1. Subject has serious heart, liver, kidney dysfunction, or mental illness.\n2. Subject diagnosed previously with any kind of malignant tumor.\n3. Subject is known to be infected with HIV or other related diseases (considering interference from the use of immune drugs).\n4. Subject is receiving targeted drugs, immunosuppressants, immunomodulators, and biological therapies.\n5. Researchers believe that subject is not suitable for enrollment.\n6. Subject can not supply sufficient sample to complete this experiment.'}, 'identificationModule': {'nctId': 'NCT06232395', 'briefTitle': 'Early Detection and Post-operative Monitoring of Gastric Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Suzhou Huhu Health & Technology Inc.'}, 'officialTitle': 'Early Detection and Post-operative Monitoring of Gastric Cancer Using Circulating DNA in Blood Samples', 'orgStudyIdInfo': {'id': '2311285-6'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'malignant group', 'description': 'Subjects diagnosed with gastric cancer.', 'interventionNames': ['Diagnostic Test: DNA test']}, {'label': 'non-malignant group', 'description': 'Healthy individuals and subjects with gastritis, gastric ulcer, gastric polyp or other benign gastric diseases.', 'interventionNames': ['Diagnostic Test: DNA test']}], 'interventions': [{'name': 'DNA test', 'type': 'DIAGNOSTIC_TEST', 'description': 'circulating DNA test', 'armGroupLabels': ['malignant group', 'non-malignant group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200032', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Dazhi Xu, MD., PhD,', 'role': 'CONTACT', 'email': 'jiangnan@sz-hoho.com', 'phone': '+8613862036541'}, {'name': 'Nan Jiang', 'role': 'CONTACT', 'email': 'jn100@qq.com', 'phone': '+8615862461212'}, {'name': 'Dazhi Xu, MD., PhD,', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Fudan University Shanghai Cancer Center.', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '200032', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Dazhi Xu, MD., PhD', 'role': 'CONTACT', 'email': 'jiangnan@sz-hoho.com', 'phone': '+8613862036541'}, {'name': 'Nan Jiang', 'role': 'CONTACT', 'email': 'jn100@qq.com', 'phone': '+8615862461212'}, {'name': 'Dazhi Xu, MD., PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Fudan University Shanghai Cancer Center.', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Suzhou Huhu Health & Technology Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Fudan University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}