Ignite Creation Date:
2025-12-24 @ 10:34 PM
Ignite Modification Date:
2025-12-25 @ 8:06 PM
Study NCT ID:
NCT03559335
Status:
COMPLETED
Last Update Posted:
2021-09-22
First Post:
2018-06-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Inflammation Biomarkers in the Diagnosis of Postoperative Infectious Complications in Colorectal Cancer Surgery
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2021-05-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-21', 'studyFirstSubmitDate': '2018-06-06', 'studyFirstSubmitQcDate': '2018-06-06', 'lastUpdatePostDateStruct': {'date': '2021-09-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative inflammatory complications', 'timeFrame': '30 days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Colorectal cancer', 'Biomarkers', 'Neutrophil CD64', 'Monocyte Human Leukocyte Antigen - DR', 'Postoperative Infectious Complications', 'C-reactive protein (CRP)', 'Procalcitonin (PCT)'], 'conditions': ['Colorectal Cancer']}, 'referencesModule': {'references': [{'pmid': '33047583', 'type': 'DERIVED', 'citation': 'Achkasov SI, Sukhina MA, Sushkov OI, Nabiev EN, Shakhmatov DG, Tarasov MA, Moskalev AI. [The role of neutrophil CD64 index in the diagnosis of infectious complications after colorectal resection]. Khirurgiia (Mosk). 2020;(10):29-35. doi: 10.17116/hirurgia202010129. Russian.'}]}, 'descriptionModule': {'briefSummary': 'This is a longitudinal, single-center, prospective study to determine the efficiency of WBC Count, CRP, PCT, Neutrophil CD64 and Monocyte Human Leukocyte Antigen- DR in the diagnosis of postoperative infectious complications in colorectal cancer surgery', 'detailedDescription': 'Blood samples for inflammation markers are carried out from patients with сolorectal cancer surgery in a single center on the day of the surgery in the operating room before intravenous fluid application started. Each patient receives systemic antibiotic prophylaxis for gramnegative and anaerobic bacteria on induction of anesthesia and prior to skin incision. A standardized protocol for general and epidural anesthesia is used. Values of WBC count, CRP, PCT, CD64n and HLA-DR monocyte are recorded before surgery and after surgery on POD (postoperative day) 1, 3 and 6 or 7. SIRS criteria on POD 1, 3, 6 or 7 and postoperative infections up to 30 days after surgery are recorded. SSIs (incisional, organ / space), pneumonia, central venous catheter related bloodstream infections (CRBSIs), urinary tract infections (UTIs) and enterocolitis records are taken. Microbial cultures are using as the gold standard. Criteria for SIRS reconsidered in the year 2001 by SCCM / ESICM / ACCP / ATS / SIS International Sepsis Definitions Conference and criteria for Dosage Control and Prevention (CDC) are taken into consideration. After discharge, each patient is being monitored by outpatient clinic examinations. The study will recruit approximately 100 patients during three consecutive years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with colorectal cancer who undergo colorectal surgery at State Scientific Center of Coloproctology.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have a elective colorectal resection for colorectal cancer\n* Have signed approved informed consent form for the study\n\nExclusion Criteria:\n\n* Significant simultaneous surgical procedure (e.g., liver resection of metastasis)\n* Bacterial infection at the time of surgery or antimicrobial therapy up to 4 weeks before surgery\n* Neo-adjuvant chemotherapy and/or radiotherapy\n* Autoimmune conditions\n* Inflammatory bowel diseases'}, 'identificationModule': {'nctId': 'NCT03559335', 'briefTitle': 'Inflammation Biomarkers in the Diagnosis of Postoperative Infectious Complications in Colorectal Cancer Surgery', 'organization': {'class': 'OTHER_GOV', 'fullName': 'State Scientific Centre of Coloproctology, Russian Federation'}, 'officialTitle': 'WBC Count, CRP, PCT, Neutrophil CD64 and Monocyte Human Leukocyte Antigen- DR Expression in the Diagnosis of Postoperative Infectious Complications in Colorectal Cancer Surgery', 'orgStudyIdInfo': {'id': '79'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients after colorectal cancer surgery'}]}, 'contactsLocationsModule': {'locations': [{'zip': '123423', 'city': 'Moscow', 'country': 'Russia', 'facility': 'State Scientific Centre of Coloproctology', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'State Scientific Centre of Coloproctology, Russian Federation', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor Sc.State Scientific Centre of Coloproctology, Head of Surgical department of sugery and oncology of colon, Moscow,Russian Federation', 'investigatorFullName': 'Achkasov Sergey', 'investigatorAffiliation': 'State Scientific Centre of Coloproctology, Russian Federation'}}}}