Ignite Creation Date:
2025-12-24 @ 4:11 PM
Ignite Modification Date:
2026-01-26 @ 11:32 PM
Study NCT ID:
NCT03449966
Status:
UNKNOWN
Last Update Posted:
2019-01-11
First Post:
2018-02-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Ability of pCLE and WLE for Diagnosis and Cancer Tissue Acquisition in Advanced Gastric Cancer After Chemotherapy Status
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'All procedures were performed with both WLE and pCLE. One patient underwent both WLE and pCLE. Target biopsy under pCLE and random biopsy at cancer lesion under WLE will be done for one patient. The proportion of remnant cancer cells in biopsy samples will be compared.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 55}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-02-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2019-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-01-10', 'studyFirstSubmitDate': '2018-02-22', 'studyFirstSubmitQcDate': '2018-02-22', 'lastUpdatePostDateStruct': {'date': '2019-01-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The percentage of remnant cancer cells in biopsy samples', 'timeFrame': 'within the first day after pCLE', 'description': 'The percentage of remnant cancer cells in biopsy samples according to the method of endoscopic method, probe-based confocal laser endomicroscopy versus white light endoscopy'}], 'secondaryOutcomes': [{'measure': 'pCLE findings of residual cancer cells after chemotherapy', 'timeFrame': 'within the first day after pCLE', 'description': 'The specific findins of remnant cancer cells under probe-based confocal laser endomicroscopy (ex. Destruction of gland structure, increased numbers of blood vessel, dark cells…)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pCLE', 'confocal', 'Advanced gastric cancer', 'chemotherapy'], 'conditions': ['Advanced Gastric Cancer', 'Neoadjuvant Chemotherapy', 'Palliative Chemotherapy']}, 'descriptionModule': {'briefSummary': '\\* single center, prospective study First, evaluate the lesion under the white light endoscopy (WLE) → IV fluorescein sodium 0.1mL/kg → evaluate the lesion under probe-based confocal laser microendoscopy → target biopsy under the pCLE → random biopsy under WLE', 'detailedDescription': 'The purpose of this study is to conduct a study on genetic pathology, obtaining of cancer tissues is mandatory. Although the endoscopy with biopsy has been a gold standard for diagnosing gastric cancer, percentage of cancer cells in biopsy samples of patients after chemotherapy is usually 30% or less. Because cancer cells are often replaced with regenerative cells after chemotherapy, even though there are still remnant cancer cells in the stomach. Recently, confocal laser endomicroscopy has been introduced for real-time histopathologic diagnosis in various cancers. In previous pilot study in our institution, pCLE-targeted biopsy provided superior results in terms of the proportion of cancer cells in biopsy samples compared to WLE-targeted biopsy, especially for gastric cancers with undifferentiated histology. However, there was no previous study about precious biopsy method for patients after chemotherapy. Therefore, the investigators aim to evaluate that biopsy using probe-based confocal laser endomicroscopy for remnant gastric cancer after chemotherapy will increase the percentage of cancer cells and expression ratio of tumor marker in biopsy samples.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nA. Older than 20 years old and younger than 80 years old B. Patients who completed neoadjuvant chemotherapy with AGC C. Patients who underwent palliative chemotherapy with AGC\n\nExclusion Criteria:\n\nA. Previous subtotal gastrectomy B. Previous EMR/ESD history C. Significant cardiopulmonary disease D. Active hepatitis or severe hepatic dysfunction E. Severe renal dysfunction F. Severe bone marrow dysfunction G. Severe neurologic or psychotic disorder H. Pregnancy or breast feeding'}, 'identificationModule': {'nctId': 'NCT03449966', 'briefTitle': 'Comparison of Ability of pCLE and WLE for Diagnosis and Cancer Tissue Acquisition in Advanced Gastric Cancer After Chemotherapy Status', 'organization': {'class': 'OTHER', 'fullName': 'Yonsei University'}, 'officialTitle': 'Comparison of Ability of pCLE and WLE for Diagnosis and Cancer Tissue Acquisition in Advanced Gastric Cancer After Chemotherapy Status', 'orgStudyIdInfo': {'id': '4-2017-0770'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Target biopsy under pCLE', 'description': '(Cellvisio® with confocal minoprobe™, Mauna Kea Technologies, France)', 'interventionNames': ['Device: Confocal group']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Random biopsy at cancer lesion under WLE', 'description': 'WLE (GIF-HQ290, Olympus, Japan) group', 'interventionNames': ['Device: Control group']}], 'interventions': [{'name': 'Confocal group', 'type': 'DEVICE', 'otherNames': ['pCLE group'], 'description': 'Under pCLE, target biopsy at cancer lesion will be done. 5 pieces of forcep biopsy will be obtained.', 'armGroupLabels': ['Target biopsy under pCLE']}, {'name': 'Control group', 'type': 'DEVICE', 'description': 'Random biopsy around cancer lesion will be done under WLE. 5 pieces with forcep biopsy will be obtained.', 'armGroupLabels': ['Random biopsy at cancer lesion under WLE']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03722', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Sang Kil Lee, MD', 'role': 'CONTACT', 'email': 'sklee@yuhs.ac', 'phone': '82-2-2228-1996'}], 'facility': 'Yonsei university of medical center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Sang Kil Lee, MD', 'role': 'CONTACT', 'email': 'sklee@yuhs.ac', 'phone': '82-2-2228-1996'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yonsei University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}