Ignite Creation Date:
2025-12-24 @ 7:22 PM
Ignite Modification Date:
2025-12-25 @ 5:01 PM
Study NCT ID:
NCT06100003
Status:
RECRUITING
Last Update Posted:
2024-02-07
First Post:
2023-10-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Clinical Study Aims to Assess the Consistency of Clinical Efficacy in Gastric Cancer Treatment and Drug Susceptibility Outcomes Using a Novel Drug Susceptibility Testing Method
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 104}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-10-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-05', 'studyFirstSubmitDate': '2023-10-07', 'studyFirstSubmitQcDate': '2023-10-20', 'lastUpdatePostDateStruct': {'date': '2024-02-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Disease-free survival', 'timeFrame': 'From date of surgery until the date of first documented recurrence，up to 3 years', 'description': 'An Indicator of efficacy of postoperative adjuvant therapy'}, {'measure': 'Sensitivity', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Cases in which drug susceptibility results are sensitive to the antineoplastic regimen as a percentage of the cases that are effective in clinical evaluation'}, {'measure': 'Specificity', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Cases in which drug susceptibility results are resistance to the antineoplastic regimen as a percentage of the cases that are ineffective in clinical evaluation'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gastric Cancer', 'Organoids']}, 'descriptionModule': {'briefSummary': 'The study is a real-world observational clinical study. Patients diagnosed as gastric cancer through histopathology were screened and enrolled. Before anti-tumor treatment, gastroscopy biopsy tissue specimens, surgical specimens, and malignant pleural effusion or ascites specimens, etc. are collected. The investigators will perform a drug sensitivity testing based on a novel drug susceptibility testing method to test the commonly used anti-tumor treatment regimens. Patients were given conventional anti-tumor treatment according to the medical judgment of the doctors. Finally, the investigator will evaluate the consistency of clinical efficacy in gastric cancer treatment and drug susceptibility outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'patients with gastric cancer in the First Affiliated Hospital of China Medical University', 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or female, aged ≥ 18 and ≤80;\n2. Patients with gastric cancer diagnosed by histopathology;\n3. Patients who need neoadjuvant treatment; adjuvant therapy after radical surgery or palliative treatment;\n4. Fresh tumor tissue specimens or malignant pleural effusion or ascites can be obtained;\n5. Patients who sign the informed consent form, and are able to comply with the study period treatment process.\n\nExclusion Criteria:\n\n1. Inability to follow the research protocol;\n2. Inability to obtain relevant fresh specimens by biopsy/surgery/puncture;\n3. Concomitant contraindications to chemotherapy;\n4. pregnant or lactating women;\n5. Patients deemed inappropriate by investigators.'}, 'identificationModule': {'nctId': 'NCT06100003', 'briefTitle': 'A Clinical Study Aims to Assess the Consistency of Clinical Efficacy in Gastric Cancer Treatment and Drug Susceptibility Outcomes Using a Novel Drug Susceptibility Testing Method', 'organization': {'class': 'OTHER', 'fullName': 'China Medical University, China'}, 'officialTitle': 'A Real-world Observational Clinical Study Aims to Assess the Consistency of Clinical Efficacy in Gastric Cancer Treatment and Drug Susceptibility Outcomes Using a Novel Drug Susceptibility Testing Method', 'orgStudyIdInfo': {'id': 'ZKPRS-CMU1H-01'}}, 'contactsLocationsModule': {'locations': [{'zip': '110001', 'city': 'Shenyang', 'state': 'Liaoning', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Shuhui Song', 'role': 'CONTACT', 'email': '593900927@qq.com', 'phone': '02483281137'}], 'facility': 'Phase I Clinical Trials Center Of The First Hospital of China Medical University', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}], 'centralContacts': [{'name': 'Shuhui Song, bachelor', 'role': 'CONTACT', 'email': '593900927@qq.com', 'phone': '83281137', 'phoneExt': '024'}], 'overallOfficials': [{'name': 'Zhenning Wang, doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The First Affiliated Hospital of China Medical Univeristy'}, {'name': 'Funan Liu, doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The First Affiliated Hospital of China Medical Univeristy'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Funan Liu', 'class': 'OTHER'}, 'collaborators': [{'name': 'Institute of Health and Medical Technology, Hefei Institutes of Physical Science, Chinese Academy of Sciences', 'class': 'UNKNOWN'}, {'name': 'Precedo Pharmaceuticals Co. Ltd.', 'class': 'UNKNOWN'}, {'name': 'Suzhou Institute of Biomedical Engineering and Technology, Chinese Academy of Sciences, Suzhou 215163, China', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Funan Liu', 'investigatorAffiliation': 'China Medical University, China'}}}}