Ignite Creation Date:
2025-12-24 @ 12:15 PM
Ignite Modification Date:
2025-12-30 @ 7:36 PM
Study NCT ID:
NCT04434261
Status:
UNKNOWN
Last Update Posted:
2021-03-08
First Post:
2020-06-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Oncological Surgery in Times of COVID-19: Effectiveness of Preoperative Screening for Sars-Cov-2
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-05-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2021-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-03-04', 'studyFirstSubmitDate': '2020-06-15', 'studyFirstSubmitQcDate': '2020-06-15', 'lastUpdatePostDateStruct': {'date': '2021-03-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of patients with a positive test for SARS-CoV-2, detected in the preoperative screening program', 'timeFrame': 'May- December 2020', 'description': 'Describe the incidence of patients with a positive test for SARS-CoV-2, detected in the preoperative screening program in our center'}], 'secondaryOutcomes': [{'measure': 'Incidence of SARS-CoV-2 infection in the postoperative period in patients with negative screening test;', 'timeFrame': 'Up to 30 days', 'description': 'Describe the incidence of SARS-CoV-2 infection in the postoperative period in patients with negative screening test.'}, {'measure': 'Postoperative complications', 'timeFrame': 'Up to 30 days', 'description': 'Postoperative complications will be recorded, according to the Clavien-Dindo classification.'}, {'measure': 'Mortality', 'timeFrame': '30 days', 'description': 'To evaluate the risk of all-cause mortality'}, {'measure': 'Delay in the cancer treatment', 'timeFrame': 'May 2020- March 2021', 'description': 'Assess the impact of delayed cancer treatment'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['SARS-CoV-2', 'Surgical Oncology', 'PT-PCR Screening Test'], 'conditions': ['SARS-CoV-2', 'Oncology', 'Surgery']}, 'referencesModule': {'references': [{'pmid': '32395064', 'type': 'BACKGROUND', 'citation': 'Shinde RS, Naik MD, Shinde SR, Bhandare MS, Chaudhari VA, Shrikhande SV, Dcruz AK. To Do or Not to Do?-A Review of Cancer Surgery Triage Guidelines in COVID-19 Pandemic. Indian J Surg Oncol. 2020 Jun;11(2):175-181. doi: 10.1007/s13193-020-01086-7. Epub 2020 May 11.'}, {'pmid': '32066541', 'type': 'BACKGROUND', 'citation': 'Liang W, Guan W, Chen R, Wang W, Li J, Xu K, Li C, Ai Q, Lu W, Liang H, Li S, He J. Cancer patients in SARS-CoV-2 infection: a nationwide analysis in China. Lancet Oncol. 2020 Mar;21(3):335-337. doi: 10.1016/S1470-2045(20)30096-6. Epub 2020 Feb 14. No abstract available.'}, {'pmid': '32432781', 'type': 'BACKGROUND', 'citation': 'Romanzi A, Galletti M, Macchi L, Putorti A, Rossi F, Scolaro R, Vannelli A. Awake laparotomy: is locoregional anesthesia a functional option for major abdominal surgeries in the COVID-19 era? Eur Rev Med Pharmacol Sci. 2020 May;24(9):5162-5166. doi: 10.26355/eurrev_202005_21211.'}, {'pmid': '32142621', 'type': 'BACKGROUND', 'citation': 'Wang H, Zhang L. Risk of COVID-19 for patients with cancer. Lancet Oncol. 2020 Apr;21(4):e181. doi: 10.1016/S1470-2045(20)30149-2. Epub 2020 Mar 3. No abstract available.'}, {'pmid': '32007143', 'type': 'BACKGROUND', 'citation': 'Chen N, Zhou M, Dong X, Qu J, Gong F, Han Y, Qiu Y, Wang J, Liu Y, Wei Y, Xia J, Yu T, Zhang X, Zhang L. Epidemiological and clinical characteristics of 99 cases of 2019 novel coronavirus pneumonia in Wuhan, China: a descriptive study. Lancet. 2020 Feb 15;395(10223):507-513. doi: 10.1016/S0140-6736(20)30211-7. Epub 2020 Jan 30.'}, {'pmid': '32031570', 'type': 'BACKGROUND', 'citation': 'Wang D, Hu B, Hu C, Zhu F, Liu X, Zhang J, Wang B, Xiang H, Cheng Z, Xiong Y, Zhao Y, Li Y, Wang X, Peng Z. Clinical Characteristics of 138 Hospitalized Patients With 2019 Novel Coronavirus-Infected Pneumonia in Wuhan, China. JAMA. 2020 Mar 17;323(11):1061-1069. doi: 10.1001/jama.2020.1585.'}, {'pmid': '32345594', 'type': 'BACKGROUND', 'citation': 'Dai M, Liu D, Liu M, Zhou F, Li G, Chen Z, Zhang Z, You H, Wu M, Zheng Q, Xiong Y, Xiong H, Wang C, Chen C, Xiong F, Zhang Y, Peng Y, Ge S, Zhen B, Yu T, Wang L, Wang H, Liu Y, Chen Y, Mei J, Gao X, Li Z, Gan L, He C, Li Z, Shi Y, Qi Y, Yang J, Tenen DG, Chai L, Mucci LA, Santillana M, Cai H. Patients with Cancer Appear More Vulnerable to SARS-CoV-2: A Multicenter Study during the COVID-19 Outbreak. Cancer Discov. 2020 Jun;10(6):783-791. doi: 10.1158/2159-8290.CD-20-0422. Epub 2020 Apr 28.'}, {'pmid': '32372035', 'type': 'BACKGROUND', 'citation': 'Tan KK, Moran BJ, Solomon MJ. Avoiding collateral mortality in a pandemic - time to change our mindset in surgical oncology. Nat Rev Clin Oncol. 2020 Jul;17(7):383-385. doi: 10.1038/s41571-020-0383-1.'}, {'pmid': '32249098', 'type': 'BACKGROUND', 'citation': 'Tuech JJ, Gangloff A, Di Fiore F, Michel P, Brigand C, Slim K, Pocard M, Schwarz L. Strategy for the practice of digestive and oncological surgery during the Covid-19 epidemic. J Visc Surg. 2020 Jun;157(3S1):S7-S12. doi: 10.1016/j.jviscsurg.2020.03.008. Epub 2020 Mar 31.'}, {'pmid': '32282023', 'type': 'BACKGROUND', 'citation': 'Schrag D, Hershman DL, Basch E. Oncology Practice During the COVID-19 Pandemic. JAMA. 2020 May 26;323(20):2005-2006. doi: 10.1001/jama.2020.6236. No abstract available.'}, {'pmid': '32386473', 'type': 'BACKGROUND', 'citation': 'Bourget-Murray J, Heard BJ, Bansal R, Johnson AS, Powell J. Postoperative fever in the time of COVID-19. Can J Surg. 2020 May 8;63(3):E231-E232. doi: 10.1503/cjs.004720.'}, {'pmid': '32270420', 'type': 'BACKGROUND', 'citation': 'Bartlett DL, Howe JR, Chang G, Crago A, Hogg M, Karakousis G, Levine E, Maker A, Mamounas E, McGuire K, Merchant N, Shibata D, Sohn V, Solorzano C, Turaga K, White R, Yang A, Yoon S; Society of Surgical Oncology. Management of Cancer Surgery Cases During the COVID-19 Pandemic: Considerations. Ann Surg Oncol. 2020 Jun;27(6):1717-1720. doi: 10.1245/s10434-020-08461-2. Epub 2020 Apr 8. No abstract available.'}, {'pmid': '32425247', 'type': 'BACKGROUND', 'citation': 'Tilmans G, Chenevas-Paule Q, Muller X, Breton A, Mohkam K, Ducerf C, Mabrut JY, Lesurtel M. Surgical outcomes after systematic preoperative severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) screening. Surgery. 2020 Aug;168(2):209-211. doi: 10.1016/j.surg.2020.05.006. Epub 2020 May 18. No abstract available.'}, {'pmid': '15273542', 'type': 'BACKGROUND', 'citation': 'Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.'}, {'pmid': '32479829', 'type': 'BACKGROUND', 'citation': 'COVIDSurg Collaborative. Mortality and pulmonary complications in patients undergoing surgery with perioperative SARS-CoV-2 infection: an international cohort study. Lancet. 2020 Jul 4;396(10243):27-38. doi: 10.1016/S0140-6736(20)31182-X. Epub 2020 May 29.'}, {'pmid': '32445710', 'type': 'BACKGROUND', 'citation': 'Peak CM, Kahn R, Grad YH, Childs LM, Li R, Lipsitch M, Buckee CO. Individual quarantine versus active monitoring of contacts for the mitigation of COVID-19: a modelling study. Lancet Infect Dis. 2020 Sep;20(9):1025-1033. doi: 10.1016/S1473-3099(20)30361-3. Epub 2020 May 20.'}, {'pmid': '32675491', 'type': 'BACKGROUND', 'citation': 'Ganesh Kumar N, Drolet BC. COVID-19 - Implications on and of Surgical Practices: Where Do We Draw the Line? Ann Surg. 2020 Aug;272(2):e45-e46. doi: 10.1097/SLA.0000000000004009. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'To evaluate the incidence of patients with a positive test for SARS-CoV-2, performed in the preoperative screening for patients treated at the institution', 'detailedDescription': 'Cohort, prospective, observational study to evaluate the incidence of asymptomatic patients with a positive SARS-CoV-2 test detected in the preoperative screening program of the institution.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All patients with scheduled elective surgery, including all types of cancer', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with elective surgery scheduled at the IBCC, including those diagnosed with any type of cancer;\n* Patients who will undergo the screening test for SARS-COV-2 by RT-PCR (nasal swab), according to the guidelines and protocol of the hospital\n\nExclusion Criteria:\n\n* Urgent or emergency surgery;\n* Screening test for SARS-COV-2 not performed\n* Incomplete data in the institutional database'}, 'identificationModule': {'nctId': 'NCT04434261', 'acronym': 'ASTANA', 'briefTitle': 'Oncological Surgery in Times of COVID-19: Effectiveness of Preoperative Screening for Sars-Cov-2', 'organization': {'class': 'OTHER', 'fullName': 'Instituto Brasileiro de Controle do Cancer'}, 'officialTitle': 'Oncological Surgery in Times of COVID-19: Effectiveness of Preoperative Screening for Sars-Cov-2', 'orgStudyIdInfo': {'id': '33467320.0.0000.0072'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients tested for SARS-CoV-2', 'description': 'Patients who underwent the preoperative screening program for SARS-CoV-2', 'interventionNames': ['Diagnostic Test: PT-PCR test for SARS-CoV-2']}], 'interventions': [{'name': 'PT-PCR test for SARS-CoV-2', 'type': 'DIAGNOSTIC_TEST', 'description': 'Screening test for the diagnosis of SARS-CoV-2 in asymptomatic patients', 'armGroupLabels': ['Patients tested for SARS-CoV-2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'São Paulo', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Alayne Yamada, PhD', 'role': 'CONTACT', 'email': 'alayne.pesquisa@ibcc-mooca.org.br', 'phone': '+551134744242'}, {'name': 'Andre Lopes, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Instituto Brasileiro de Controle do Cancer - IBCC', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'centralContacts': [{'name': 'Andre Lopes, MD', 'role': 'CONTACT', 'email': 'andrelopes1002@hotmail.com', 'phone': '+551134744242'}, {'name': 'Alayne Yamada, PhD', 'role': 'CONTACT', 'email': 'alayne.pesquisa@ibcc-mooca.org.br', 'phone': '+551134744242'}], 'overallOfficials': [{'name': 'Andre Lopes, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Instituto Brasileiro de Controle do Cancer'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'The data will become available in a scientific publication', 'ipdSharing': 'YES', 'description': 'All IPD that underlie results in a publication', 'accessCriteria': 'There are no sharing Access Criteria'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Instituto Brasileiro de Controle do Cancer', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}