Ignite Creation Date:
2025-12-24 @ 10:08 PM
Ignite Modification Date:
2025-12-25 @ 7:44 PM
Study NCT ID:
NCT03581435
Status:
UNKNOWN
Last Update Posted:
2018-07-10
First Post:
2018-06-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of Circulating Exosome Proteomics In Gallbladder Carcinoma Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005706', 'term': 'Gallbladder Neoplasms'}], 'ancestors': [{'id': 'D001661', 'term': 'Biliary Tract Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005705', 'term': 'Gallbladder Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Serum Tumor tissue'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2019-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-07-08', 'studyFirstSubmitDate': '2018-06-26', 'studyFirstSubmitQcDate': '2018-07-08', 'lastUpdatePostDateStruct': {'date': '2018-07-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Characterization of the protein profile in tumor derived exosomes from the gallbladder carcinoma patients', 'timeFrame': 'Up to 2 years from start of study', 'description': 'Proteomics studies will be done in both tumor tissue and the circulating exosomes from blood specimens. The specific protein A in the circulating exosomes from the gallbladder carcinoma patients will be selected for further analysis.'}, {'measure': 'The expression of protein A in the circulating exosomes from patients', 'timeFrame': 'Up to 2 years from start of study', 'description': 'The expression of protein A （which is selected from outcome 1） in the circulating exosomes from patients will be detected by flow cytometry analysis. The ROC curve of A+ circulating exosomes will be done to compare with the clinical standard tumour biomarker (e.g. CA199) for patients with gallbladder carcinoma patients.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Proteinosis', 'Gallbladder Carcinoma']}, 'descriptionModule': {'briefSummary': 'This research will be the first study for exosome purified from blood in gallbladder carcinoma patients. Proteomics studies will be done in both tumor tissue and the circulating exosome from blood specimens. Then, the potential prognostic and predictive biomarkers will be searched by bioinformatics to find the correlations between exosome biomarkers and gallbladder carcinoma.', 'detailedDescription': 'Background:\n\nExosomes are formed by inward budding of late endosomes, producing multivesicular bodies (MVBs), and are released into the environment by fusion of the MVBs with the plasma membrane. It has been demonstrated that the content and function of exosomes depends on the originating cell and the conditions under which they are produced. Tumor exosome production, transfer and education of bone marrow cells supports tumor growth and metastasis.\n\nAims of the study:\n\nProteomics studies will be done in both tumor tissue and the circulating exosome from the gallbladder carcinoma patients. Then, the potential prognostic and predictive biomarkers will be searched by bioinformatics to find the correlations between exosome biomarkers and gallbladder carcinoma.\n\nMaterials and Methods:\n\nThe investigators will conduct a case-control study in 11 hospitals from China. Cases will be the patients with newly-diagnosed gallbladder carcinoma. The controls will be matched （1：1）by sex，race and age which will be selected from the patients receiving cholecystectomy due to gallstones from the same hospital with the cases. A total of 50 patients with gallbladder carcinoma will be recruited. The investigators will obtain the blood and tumor tissue samples for further analysis of proteomics studies. Exosome from blood specimens will be isolated and purified by sucrose gradient ultracentrifugation. The potential prognostic and predictive biomarkers will be searched by bioinformatics to find the correlations between exosome biomarkers and gallbladder carcinoma. Data will be collected from January 2018 to December 2018.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The investigators will conduct a case-control study in 11 hospitals from China. Cases will be the patients with newly-diagnosed gallbladder carcinoma. The controls will be matched （1：1）by sex，race and age which will be selected from the patients receiving cholecystectomy due to gallstones from the same hospital with the cases. A total of 50 patients with gallbladder carcinoma will be recruited.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed with gallbladder carcinoma by imaging tests (cases) Diagnosed with chronic cholecystitis by imaging tests (hospital controls)\n\nExclusion Criteria:\n\n* The pathology diagnosis and imaging does not matched Patients with other malignant tumors Patients with other severe systemic diseases'}, 'identificationModule': {'nctId': 'NCT03581435', 'acronym': 'EXOGBC001', 'briefTitle': 'A Study of Circulating Exosome Proteomics In Gallbladder Carcinoma Patients', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Jiao Tong University School of Medicine'}, 'officialTitle': 'A Study of Circulating Exosome Proteomics In Gallbladder Carcinoma Patients', 'orgStudyIdInfo': {'id': 'EXOGBC001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'gallbladder carcinoma patients', 'description': 'Cases will be the patients with newly-diagnosed gallbladder carcinoma.'}, {'label': 'The controls', 'description': 'The controls will be matched （1：1）by sex，race and age which will be selected from the patients receiving cholecystectomy due to gallstones from the same hospital with the cases.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '200092', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'yingbin liu', 'role': 'CONTACT', 'email': 'laoniulyb@163.com', 'phone': '13918803900'}], 'facility': 'Xinhua Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'liu yingbin', 'class': 'OTHER'}, 'collaborators': [{'name': 'The First Hospital of Jilin University', 'class': 'OTHER'}, {'name': 'Shanghai Zhongshan Hosiptal', 'class': 'UNKNOWN'}, {'name': 'The First Affiliated Hospital of Bengbu Medical University', 'class': 'OTHER'}, {'name': 'Second Affiliated Hospital of Nanchang University', 'class': 'OTHER'}, {'name': 'The Affiliated Hospital of Inner Mongolia Medical University', 'class': 'OTHER'}, {'name': 'First Affiliated Hospital of Xinjiang Medical University', 'class': 'OTHER'}, {'name': 'The First Affiliated Hospital of Shanxi Medical University', 'class': 'OTHER'}, {'name': 'Jining Medical University', 'class': 'OTHER'}, {'name': 'The Affiliated Hospital of Tianjin Medical University', 'class': 'UNKNOWN'}, {'name': 'The first affiliated hospital of Zhongshan university', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'vice-president，Xinhua Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China', 'investigatorFullName': 'liu yingbin', 'investigatorAffiliation': 'Shanghai Jiao Tong University School of Medicine'}}}}