Ignite Creation Date:
2025-12-24 @ 10:53 PM
Ignite Modification Date:
2026-01-02 @ 5:13 AM
Study NCT ID:
NCT02869269
Status:
COMPLETED
Last Update Posted:
2018-01-29
First Post:
2016-07-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Circulating Immune Cell Activity Changes in Blood of Colorectal Cancer Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'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': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'whole blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 67}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-26', 'studyFirstSubmitDate': '2016-07-15', 'studyFirstSubmitQcDate': '2016-08-11', 'lastUpdatePostDateStruct': {'date': '2018-01-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-08-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'CD4 and Treg cell activity and change of percentage of CD39 and CD73', 'timeFrame': 'preoperative time', 'description': 'change of expression level of CD4 and Treg cell activity and change of percentage of CD39 and CD73(0\\~100 %)'}], 'primaryOutcomes': [{'measure': 'Circulating helper T cell activity', 'timeFrame': 'preoperative time', 'description': 'change of expression level of T cell (0\\~100 %)'}], 'secondaryOutcomes': [{'measure': 'Cytotoxic T cell and natural killer cell activity', 'timeFrame': 'preoperative time', 'description': 'change of expression level Cytotoxic T cell and natural killer cell(0\\~100 %)from 0 to 100)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Colorectal Cancer']}, 'descriptionModule': {'briefSummary': "Previous studies have shown that colorectal cancer patients' prognosis and overall survival was related with immune cell expression in patients' tissue. However, the circulating immune cell activity changes in patients' blood has few studies. The purpose of this study is to analyze the variation of circulating immune cell activity in colorectal patients' blood which is classed as clinical staging.", 'detailedDescription': 'The patients were classed as clinical staging\n\n1. Early (stage1+2) and Late(stage3+4)\n2. regional lymph node metastasis\n3. Distant metastasis\n4. TNM stage'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing colorectal surgery', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patient who was planned to undergo colorectal cancer surgery.\n\nExclusion Criteria:\n\n* age \\< 20 years old\n* history of hypersensitivity reaction in propofol or sevoflurane\n* history of previous cancer\n* patient with ongoing inflammation'}, 'identificationModule': {'nctId': 'NCT02869269', 'briefTitle': 'A Study of Circulating Immune Cell Activity Changes in Blood of Colorectal Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': 'Konkuk University Medical Center'}, 'officialTitle': 'A Study of Circulating Immune Cell Activity Changes in Blood of Colorectal Cancer Patients', 'orgStudyIdInfo': {'id': 'KUH1160096'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Early stage', 'description': 'patients who diagnosed as TNM stage 1 and 2', 'interventionNames': ['Device: Early stage']}, {'label': 'Late stage', 'description': 'patients who diagnosed as TNM stage 3 and 4', 'interventionNames': ['Device: Late stage']}], 'interventions': [{'name': 'Early stage', 'type': 'DEVICE', 'otherNames': ['stage1+2'], 'description': 'patients who classed as clinical stage 1 and 2', 'armGroupLabels': ['Early stage']}, {'name': 'Late stage', 'type': 'DEVICE', 'otherNames': ['stage3+4'], 'description': 'patients who classed as clinical stage 3 and 4', 'armGroupLabels': ['Late stage']}]}, 'contactsLocationsModule': {'locations': [{'zip': '143-729', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Konkuk University Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Seong-Hyop Kim, M.D,Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Konkuk University Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Konkuk University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Seong-Hyop Kim', 'investigatorAffiliation': 'Konkuk University Medical Center'}}}}