Ignite Creation Date:
2025-12-25 @ 12:20 AM
Ignite Modification Date:
2025-12-25 @ 10:24 PM
Study NCT ID:
NCT06928558
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-04-15
First Post:
2025-04-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Preoperative Anemia in the Oncology Population and Associated Mortality
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000740', 'term': 'Anemia'}], 'ancestors': [{'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 850}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-04-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-06-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-07', 'studyFirstSubmitDate': '2025-04-07', 'studyFirstSubmitQcDate': '2025-04-07', 'lastUpdatePostDateStruct': {'date': '2025-04-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of preoperative anemia', 'timeFrame': '1 year', 'description': 'To quantify the prevalence of preoperative anemia in the oncology surgical population of the National Cancer Institute and its impact on postoperative outcomes.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Anemia', 'Oncologic Surgery', 'Anesthesia'], 'conditions': ['Anemia', 'Oncologic Surgery']}, 'referencesModule': {'references': [{'pmid': '31230739', 'type': 'BACKGROUND', 'citation': 'Sim YE, Abdullah HR. Implications of Anemia in the Elderly Undergoing Surgery. Clin Geriatr Med. 2019 Aug;35(3):391-405. doi: 10.1016/j.cger.2019.04.001. Epub 2019 May 27.'}, {'pmid': '16301274', 'type': 'BACKGROUND', 'citation': 'Goodnough LT, Shander A, Spivak JL, Waters JH, Friedman AJ, Carson JL, Keating EM, Maddox T, Spence R. Detection, evaluation, and management of anemia in the elective surgical patient. Anesth Analg. 2005 Dec;101(6):1858-1861. doi: 10.1213/01.ANE.0000184124.29397.EB.'}, {'pmid': '21982521', 'type': 'BACKGROUND', 'citation': 'Musallam KM, Tamim HM, Richards T, Spahn DR, Rosendaal FR, Habbal A, Khreiss M, Dahdaleh FS, Khavandi K, Sfeir PM, Soweid A, Hoballah JJ, Taher AT, Jamali FR. Preoperative anaemia and postoperative outcomes in non-cardiac surgery: a retrospective cohort study. Lancet. 2011 Oct 15;378(9800):1396-407. doi: 10.1016/S0140-6736(11)61381-0. Epub 2011 Oct 5.'}]}, 'descriptionModule': {'briefSummary': 'Anemia is a highly prevalent condition in the surgical population (1, 2). On the other hand, the oncology population is at higher risk of developing anemia due to specific treatments for the disease, such as chemotherapy and radiotherapy. Preoperative anemia has been associated with an increased risk of postoperative morbidity and even mortality (3). Despite this, the prevalence of preoperative anemia in the Chilean oncology population has not been quantified. To answer this question, a retrospective cohort study was designed between January and December 2022 to quantify the prevalence of anemia in the surgical population of the National Cancer Institute. In addition, the impact on morbidity and mortality at 30 days, 6 months, and 1 year will be evaluated. Statistical analysis will be performed using R. Studio Version 2023.09.1+494 (2023.09.1+494).', 'detailedDescription': "General Objective:\n\nTo quantify the prevalence of preoperative anemia in the National Cancer Institute's oncology surgical population and its impact on postoperative outcomes.\n\nSpecific Objectives:\n\n1. To quantify the prevalence of preoperative anemia in the National Cancer Institute's oncology population.\n2. To stratify the prevalence of preoperative anemia in the National Cancer Institute's oncology population by severity.\n3. To assess 30-day, 6-month, and 1-year mortality in cancer patients with and without anemia in the National Cancer Institute's oncology population."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Consecutive patients operated at the National Cancer Institute will be included in a retrospective cohort study between January and December 2022.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients over 18 years of age\n* Oncologic surgery with curative intent\n\nExclusion Criteria:\n\n* Emergency surgery\n* Patients who received a preoperative transfusion\n* Patients without a preoperative blood count'}, 'identificationModule': {'nctId': 'NCT06928558', 'briefTitle': 'Preoperative Anemia in the Oncology Population and Associated Mortality', 'organization': {'class': 'OTHER', 'fullName': 'University of Chile'}, 'officialTitle': 'Prevalence of Preoperative Anemia in the Oncology Population and Associated Mortality', 'orgStudyIdInfo': {'id': 'Instituto Nacional del Cáncer'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Surgical oncology patients', 'description': 'Oncology patients over 18 years of age, scheduled for surgery with curative intent'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Roberto A González, MD', 'role': 'CONTACT', 'email': 'robgonzalez@uchile.cl', 'phone': '+56999397515'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Chile', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Anesthesiologist', 'investigatorFullName': 'Roberto Gonzalez Cornejo', 'investigatorAffiliation': 'University of Chile'}}}}