Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2025-12-25 @ 9:55 PM
Study NCT ID:
NCT04660058
Status:
COMPLETED
Last Update Posted:
2023-01-31
First Post:
2020-12-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Associations Among Serum and Gastric Juice Bile Acid Profile, Bile Acid-microbiota Cross-talk in Stomach and the Development of Gastric Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001655', 'term': 'Bile Reflux'}, {'id': 'D013274', 'term': 'Stomach Neoplasms'}], 'ancestors': [{'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D004383', 'term': 'Duodenogastric Reflux'}, {'id': 'D013272', 'term': 'Stomach Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'serum and gastric juice samples will not be retained; pathological tissue samples will be retained in Xijing Hospital'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 73}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-12-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2022-01-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-29', 'studyFirstSubmitDate': '2020-12-02', 'studyFirstSubmitQcDate': '2020-12-02', 'lastUpdatePostDateStruct': {'date': '2023-01-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'corelation between the bile acid profile and gastric mucosa diseases', 'timeFrame': 'up to 6 months', 'description': 'Investigators evaluate the corelation between the bile acid profile and gastric mucosa diseases according to the results of UPLC-MS/MS and pathological .'}, {'measure': 'corelation between the bile acid profile and gastric microbiota in different groups', 'timeFrame': 'up to 6 months', 'description': 'Investigators explore the cross-talk between bile acid and gastric microbiota according to the results of 16s rRNA sequencing'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['bile acid', 'gastric microbiota', 'Gastric Cancer', 'precancerous lesion'], 'conditions': ['Bile Reflux', 'Gastric Cancer', 'Precancerous Lesion']}, 'descriptionModule': {'briefSummary': 'To explore the associations among bile acid profile, bile acid-microbiota cross-talk and the development of gastric cancer, so as to better prevent the occurrence and development of gastric cancer', 'detailedDescription': 'This study is a case-control study. Patients, according to the pathological results, will be consecutively enrolled and divided into gastric cancer group, gastric precancerous lesions group, and chronic gastritis group. The serum and gastric juice bile acid profiles, gastric microbial composition of each group patients will be detected.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients are from Xijing Hospital', 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 18 to 75 years old, gender is not limited;\n2. No history of antibiotic or probiotic use for 8 weeks;\n3. No preoperative chemotherapy or radiation therapy prior to the examination;\n4. Voluntary intravenous blood collection, gastroscopy, extraction of gastric juice and pathological biopsy.\n5. Voluntary testing for H. pylori\n\nExclusion Criteria:\n\n1. had undergone upper gastrointestinal and colon surgery;\n2. Previous diagnosis of Malignant Tumors;\n3. Presence of a disease or medication that affects bile acid metabolism, such as endocrine or autoimmune diseases;\n4. Recent use of drugs that affect gastrointestinal motility;\n5. Presence of contraindications to endoscopy;\n6. pregnant and lactating women;\n7. Those with mental disorders;\n8. Refusal to sign the informed consent form.'}, 'identificationModule': {'nctId': 'NCT04660058', 'briefTitle': 'Associations Among Serum and Gastric Juice Bile Acid Profile, Bile Acid-microbiota Cross-talk in Stomach and the Development of Gastric Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Xijing Hospital of Digestive Diseases'}, 'officialTitle': 'Associations Among Serum and Gastric Juice Bile Acid Profile, Bile Acid-microbiota Cross-talk in Stomach and the Development of Gastric Cancer: A Case-control Study', 'orgStudyIdInfo': {'id': 'KY20202100-F-1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'chronic gastritis', 'description': 'patients with chronic non-atrophic gastritis and chronic atrophic gastritis according to histopathological results'}, {'label': 'precancerous lesion', 'description': 'patients with gastric intestinal metaplasia and intraepithelial neoplasia according to histopathological results'}, {'label': 'gastric cancer', 'description': 'patients with gastric cancer according to histopathological results'}]}, 'contactsLocationsModule': {'locations': [{'zip': '710032', 'city': "Xi'an", 'state': 'Shaanxi', 'country': 'China', 'facility': 'Xijing Hosipital of Digestive Disease', 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xijing Hospital of Digestive Diseases', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator, Clinical Professor', 'investigatorFullName': 'Yongquan Shi', 'investigatorAffiliation': 'Xijing Hospital of Digestive Diseases'}}}}