Ignite Creation Date:
2025-12-24 @ 10:35 PM
Ignite Modification Date:
2026-01-02 @ 2:21 AM
Study NCT ID:
NCT06776835
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-01-15
First Post:
2025-01-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Screening of Small Non-coding RNAs as an Auxiliary Diagnostic Biomarker 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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2023-12-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2026-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-10', 'studyFirstSubmitDate': '2025-01-10', 'studyFirstSubmitQcDate': '2025-01-10', 'lastUpdatePostDateStruct': {'date': '2025-01-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Analysis of relative quantitative of small non-coding RNAs', 'timeFrame': 'an average of 2 years', 'description': 'Relative quantitative of small non-coding RNAs are detected by quantitative RT-PCR'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stomach Neoplasms']}, 'descriptionModule': {'briefSummary': 'Gastric cancer is one of the most common malignancies of the gastrointestinal system, especially in East Asia. A host of patients are diagnosed with GC at the late stage, leading to poor patient prognosis. Therefore, there is a strong demand to develop new biomarkers to detect this tumor early. Small non-coding RNA species include microRNA (miRNA), PIWI-interacting RNA (piRNA), small interfering RNA (siRNA), tRNA-derived small RNA (tsRNA), etc. It has been demonstrated that small non-coding RNAs are involved in gastric cancer cell proliferation, metastasis, progression and survival. Hence, it is considered as an auxiliary diagnostic biomarker for gastric cancer.', 'detailedDescription': 'Gastric cancer is one of the most common malignancies of the gastrointestinal system, especially in East Asia. A host of patients are diagnosed with GC at the late stage, leading to poor patient prognosis. Therefore, there is a strong demand to develop new biomarkers to detect this tumor early.\n\nSmall non-coding RNA species include microRNA (miRNA), PIWI-interacting RNA (piRNA), small interfering RNA (siRNA), tRNA-derived small RNA (tsRNA), etc. It has been demonstrated by previous scientific researches that small non-coding RNAs are involved in gastric cancer cell proliferation, metastasis, progression and survival. Hence, it is considered as a new biomarker panel for gastric cancer.\n\nThe purpose of the present clinical trail is to explore the correlation between small non-coding RNAs panel and early gastric cancer, and to elucidate the possibility of small non-coding RNAs panel as a biomarker for gastric cancer. Verify the experimental purpose by monitoring the relative quantification of small non-coding RNAs panel through high-throughput sequencing and qRT PCR technology.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'AFFILIATED HOSPITAL OF NANTONG UNIVERSITY', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Having signed informed consent\n* Age≥ 18 years old and ≤ 85 years old\n* Histologically confirmed gastric cancer\n\nExclusion Criteria:\n\n* Other previous malignancy within 5 year\n* Surgery (excluding diagnostic biopsy) within 4 weeks prior to study\n* Pregnancy or lactation period\n* Legal incapacity'}, 'identificationModule': {'nctId': 'NCT06776835', 'briefTitle': 'Screening of Small Non-coding RNAs as an Auxiliary Diagnostic Biomarker for Gastric Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Affiliated Hospital of Nantong University'}, 'officialTitle': 'Screening of Small Non-coding RNAs as an Auxiliary Diagnostic Biomarker for Gastric Cancer and Exploring Its Correlation With Prognostic Diagnosis', 'orgStudyIdInfo': {'id': '2023-L166'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Gastric cancer cases from medical centers in China', 'description': 'Measurement of levels of circulating small non-coding RNAs', 'interventionNames': ['Diagnostic Test: Analysis of relative quantitative of small non-coding RNAs']}, {'label': 'Controls from medical centers in China', 'description': 'Measurement of levels of circulating small non-coding RNAs', 'interventionNames': ['Diagnostic Test: Analysis of relative quantitative of small non-coding RNAs']}], 'interventions': [{'name': 'Analysis of relative quantitative of small non-coding RNAs', 'type': 'DIAGNOSTIC_TEST', 'description': 'Each participant was enrolled to assess the of relative quantitative of small non-coding RNAs', 'armGroupLabels': ['Controls from medical centers in China', 'Gastric cancer cases from medical centers in China']}]}, 'contactsLocationsModule': {'locations': [{'zip': '226001', 'city': 'Nantong', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Affiliated Hospital of Nantong University', 'geoPoint': {'lat': 32.03028, 'lon': 120.87472}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Affiliated Hospital of Nantong University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Jiangsu Cancer Institute & Hospital', 'class': 'OTHER'}, {'name': 'The Affiliated Tumor Hospital of Nantong University, Nantong, Jiangsu Province, China', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}