Ignite Creation Date:
2025-12-24 @ 10:54 PM
Ignite Modification Date:
2026-01-05 @ 5:17 PM
Study NCT ID:
NCT05029869
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-08-13
First Post:
2021-08-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Monitoring Minimal Residual Disease in Gastric Cancer by Liquid Biopsy Study Description
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': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-10-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-08', 'studyFirstSubmitDate': '2021-08-25', 'studyFirstSubmitQcDate': '2021-08-25', 'lastUpdatePostDateStruct': {'date': '2025-08-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The sensitivity of MRD detection using ctDNA as the biomarker', 'timeFrame': '2 years after surgery', 'description': 'The percentage of positive ctDNA detection among participants who experience disease recurrence or metastasis'}, {'measure': 'The specificity of MRD detection using ctDNA as the biomarker', 'timeFrame': '2 years after surgery', 'description': 'The percentage of positive ctDNA detection among participants who do not experience disease recurrence or metastasis'}], 'secondaryOutcomes': [{'measure': 'Leading time between ctDNA detection and cancer recurrence detected by conventional methods', 'timeFrame': '2 years after surgery', 'description': 'Time is measured between first positive ctDNA detection and first cancer recurrence detected by conventional methods'}, {'measure': 'Mean ctDNA level (MTM/ml) of gastric cancer before operation', 'timeFrame': 'Within 14 days before operation', 'description': 'The mean ctDNA level in gastric cancer patients before operation'}, {'measure': 'Mutation profile of gastric cancer', 'timeFrame': 'Within 14 days before operation', 'description': 'Profiling of the most frequent gene mutations'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gastric Cancer', 'ctDNA']}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate the use of Next Generation Sequencing (NGS) to detect circulating tumor DNA in gastric cancer patients after gastrectomy', 'detailedDescription': 'Gastric cancer is the fourth most common cancer in Vietnam with high mortality rate. Patients at early stages undergo radical gastrectomy with curative intent, but the remaining tumor cells, termed as minimal residual disease (MRD), can later cause relapse. Conventional methods to monitor MRD such as imaging and blood tests for biomarkers such as CEA are not sensitive and specific enough. ctDNA has recently emerged as a promising noninvasive marker with high accuracy to monitor MRD and detect relapse in many cancers such as breast and colorectal cancers. However, its application in gastric cancer has not been extensively evaluated. Therefore, this study aims to use advanced NGS technologies to detect ctDNA in liquid biopsy as a biomarker to monitor MRD after radical gastrectomy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with newly diagnosed and untreated gastric adenocarcinoma', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or Female patients aged 18 years and older\n2. Histologically proven primary gastric adenocarcinoma before surgery\n3. Clinical stage is locally advanced cT2-4a any N and M0\n4. In initial evaluation, patient can undergo radical gastrectomy and lymphadenectomy\n5. No preoperative therapy, including chemotherapy and radiotherapy\n6. No known cancer diagnosis within last five years\n7. Signed informed consent\n\nExclusion Criteria:\n\n1. Gastrectomy cannot be achieved during operation due to metastasis\n2. Patient fails to follow-up and provide postoperative samples'}, 'identificationModule': {'nctId': 'NCT05029869', 'briefTitle': 'Monitoring Minimal Residual Disease in Gastric Cancer by Liquid Biopsy Study Description', 'organization': {'class': 'OTHER', 'fullName': 'University Medical Center Ho Chi Minh City (UMC)'}, 'officialTitle': 'Monitoring Minimal Residual Disease in Gastric Cancer by Liquid Biopsy', 'orgStudyIdInfo': {'id': '81/GCN-HDDD 2021'}}, 'armsInterventionsModule': {'interventions': [{'name': 'ctDNA', 'type': 'DIAGNOSTIC_TEST', 'description': 'The blood samples for ctDNA and other tumor markers will be first collected within 14 days before surgery, and then be tested after gastrectomy in scheduled interval'}]}, 'contactsLocationsModule': {'locations': [{'zip': '700000', 'city': 'Ho Chi Minh City', 'country': 'Vietnam', 'facility': 'University Medical Center Ho Chi Minh City', 'geoPoint': {'lat': 10.82302, 'lon': 106.62965}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Medical Center Ho Chi Minh City (UMC)', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}