Ignite Creation Date:
2025-12-24 @ 4:59 PM
Ignite Modification Date:
2025-12-29 @ 8:57 AM
Study NCT ID:
NCT03514550
Status:
COMPLETED
Last Update Posted:
2019-06-03
First Post:
2018-04-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Anesthesia on Immunity in Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007680', 'term': 'Kidney Neoplasms'}], 'ancestors': [{'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015742', 'term': 'Propofol'}, {'id': 'D000077149', 'term': 'Sevoflurane'}, {'id': 'D000767', 'term': 'Anesthesia, Epidural'}], 'ancestors': [{'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D008738', 'term': 'Methyl Ethers'}, {'id': 'D004987', 'term': 'Ethers'}, {'id': 'D006845', 'term': 'Hydrocarbons, Fluorinated'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D000765', 'term': 'Anesthesia, Conduction'}, {'id': 'D000758', 'term': 'Anesthesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-05-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2019-05-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-31', 'studyFirstSubmitDate': '2018-04-13', 'studyFirstSubmitQcDate': '2018-04-20', 'lastUpdatePostDateStruct': {'date': '2019-06-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'CD 16', 'timeFrame': 'postoperative day 1', 'description': 'NK cells expression of CD16 receptor'}], 'secondaryOutcomes': [{'measure': 'CD45', 'timeFrame': 'Baseline, end of surgery, postoperative days 1, 3-4, 7', 'description': 'CD45 expression on lymphocytes measured with flow cytometry'}, {'measure': 'CD3', 'timeFrame': 'Baseline, end of surgery, postoperative days 1, 3-4, 7', 'description': 'CD3 expression on lymphocytes measured with flow cytometry'}, {'measure': 'CD19', 'timeFrame': 'Baseline, end of surgery, postoperative days 1, 3-4, 7', 'description': 'CD19 expression on lymphocytes measured with flow cytometry'}, {'measure': 'CD4', 'timeFrame': 'Baseline, end of surgery, postoperative days 1, 3-4, 7', 'description': 'CD4 expression on lymphocytes measured with flow cytometry'}, {'measure': 'CD8', 'timeFrame': 'Baseline, end of surgery, postoperative days 1, 3-4, 7', 'description': 'CD8 expression on lymphocytes measured with flow cytometry'}, {'measure': 'CD16', 'timeFrame': 'Baseline, end of surgery, postoperative days 1, 3-4, 7', 'description': 'CD16 expression on lymphocytes measured with flow cytometry'}, {'measure': 'CD25', 'timeFrame': 'Baseline, end of surgery, postoperative days 1, 3-4, 7', 'description': 'CD25 expression on lymphocytes measured with flow cytometry'}, {'measure': 'HLA-DR', 'timeFrame': 'Baseline, end of surgery, postoperative days 1, 3-4, 7', 'description': 'HLA-DR expression on lymphocytes measured with flow cytometry'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Surgery', 'Renal Cancer']}, 'descriptionModule': {'briefSummary': 'The aim of the study is a comparative study of the cellular immunity response of patients operated on for kidney cancer under total intravenous and inhalational anesthesia.', 'detailedDescription': 'The severity of perioperative immunosuppression is directly proportional to the degree of surgical stress. A series of experimental and clinical studies indicate a different effect of certain types of anesthesia on immunity. It is believed that surgical stress itself opens an opportunity for the recurrence of oncological diseases precisely due to the immunosuppressive effect. The aim of present pilot clinical study is to test a hypothesis that total intravenous anesthesia as superior to inhalational anesthesia in term of its effects on cell immunity among patients with kidney cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Surgery for renal cancer\n* Signed informed concent\n\nExclusion Criteria:\n\n* Propofol or sevoflurane intolerance\n* Contraindications for epidural anesthesia\n* Renal failure\n* Hepatic failure\n* Congestive heart failure\n* Previous hemotherapy\n* Hematological diseases'}, 'identificationModule': {'nctId': 'NCT03514550', 'briefTitle': 'Effects of Anesthesia on Immunity in Cancer', 'organization': {'class': 'NETWORK', 'fullName': 'Meshalkin Research Institute of Pathology of Circulation'}, 'officialTitle': 'Immunomodulatory Effects of Volatile and Total Intravenous Anesthesia for Patients With Renal Cancer', 'orgStudyIdInfo': {'id': 'Onko1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'total intravenous anesthesia', 'description': 'Patients, scheduled for nephrectomy for kidney cancer will receive neuraxial epidural block and propofol for perioperative anesthesia', 'interventionNames': ['Drug: Propofol', 'Procedure: Epidural block']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Volatile anesthesia', 'description': 'Patients, scheduled for nephrectomy for kidney cancer will receive neuraxial epidural block and sevoflurane for perioperative anesthesia', 'interventionNames': ['Drug: Sevoflurane', 'Procedure: Epidural block']}], 'interventions': [{'name': 'Propofol', 'type': 'DRUG', 'description': 'Propofol will be used for anesthesia during surgery', 'armGroupLabels': ['total intravenous anesthesia']}, {'name': 'Sevoflurane', 'type': 'DRUG', 'description': 'Sevoflurane will be used for anesthesia during surgery', 'armGroupLabels': ['Volatile anesthesia']}, {'name': 'Epidural block', 'type': 'PROCEDURE', 'description': 'Epidural catheterization Th9-Th10, ropivacaine for perioperative analgesia', 'armGroupLabels': ['Volatile anesthesia', 'total intravenous anesthesia']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Novosibirsk', 'country': 'Russia', 'facility': 'State Research Institute of Circulation Pathology', 'geoPoint': {'lat': 55.02259, 'lon': 82.93175}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Meshalkin Research Institute of Pathology of Circulation', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Efremov Sergey', 'investigatorAffiliation': 'Meshalkin Research Institute of Pathology of Circulation'}}}}