Ignite Creation Date:
2025-12-24 @ 7:07 PM
Ignite Modification Date:
2025-12-30 @ 1:52 AM
Study NCT ID:
NCT05221957
Status:
UNKNOWN
Last Update Posted:
2022-02-03
First Post:
2021-04-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Preoperative Correction of Anemia With Intravenously Iron in Colorectal Cancer Patients.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D000740', 'term': 'Anemia'}, {'id': 'D018798', 'term': 'Anemia, Iron-Deficiency'}], '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'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D000747', 'term': 'Anemia, Hypochromic'}, {'id': 'D000090463', 'term': 'Iron Deficiencies'}, {'id': 'D019189', 'term': 'Iron Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Propensity score matched cohort study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-01-21', 'studyFirstSubmitDate': '2021-04-14', 'studyFirstSubmitQcDate': '2022-01-21', 'lastUpdatePostDateStruct': {'date': '2022-02-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gene expression and lymphocyte infiltration of the tumor', 'timeFrame': '1 day after surgery', 'description': '770 gene expression analysis and CD3/CD8+ lymphocyte infiltration of the primary tumor'}, {'measure': 'Complications', 'timeFrame': '30 days after surgery', 'description': 'Postoperative complications after surgery measured by the Clavien-Dindo classification'}], 'secondaryOutcomes': [{'measure': 'Length of stay', 'timeFrame': 'up to 100 days', 'description': 'Length of postoperative hospital stay, until discharge or death.'}, {'measure': 'Readmission', 'timeFrame': 'Within 30 days after surgery', 'description': 'Any readmission over 24 hours in length'}, {'measure': 'Time to chemotherapy', 'timeFrame': 'up to 100 days', 'description': 'Tme from surgery to adjuvant oncological treatment for patients with high risk stage II and stage III disease'}, {'measure': 'Perioperative blood transfusions', 'timeFrame': 'from outpatient assesment to 30 days after surgery', 'description': 'Any blood transfusions measured in ml.'}, {'measure': 'Mortality', 'timeFrame': '30 days, 90 days and one year', 'description': 'Mortality'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Anemia', 'Iron-deficiency anemia'], 'conditions': ['Colorectal Cancer', 'Anemia', 'Iron-deficiency']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to examine the effects of anemia correction with intravenous administered iron on clinical outcomes and the immune response on the tumor in patients with planned colonic- or rectal cancer surgery.\n\nThe study will be performed as a retrospective propensity score-matched cohort study with an examination of immune response in tumor and clinical outcomes, between patients with anemia without correction with iron(III)isomaltoside, non-anemic patients, and anemic patients treated with iron(III)isomaltoside prior to surgery. Propensity score matching will ensure identification of controls from a pool of patients treated at the Department of Surgery, Zealand University Hospital. The two control groups will be: an anemic historical control group (group 1), and a non-anemic concurrent control group (group 2). Group 3 will be the treatment group, with patients with anemia and treated with iron(III)isomaltoside.\n\nThe study period of cases undergoing i.v. treatment will be 1st of February 2017 to 31st of October 2019 with approximately 70 cases included'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Undergoing curative intended surgery for colon or rectum cancer\n* UICC stage I-III\n\nExclusion Criteria:\n\n* Neoadjuvant oncological treatment\n* Acute / subacute surgery\n* Palliative surgery\n* Other pathology than adenocarcinoma'}, 'identificationModule': {'nctId': 'NCT05221957', 'briefTitle': 'Effects of Preoperative Correction of Anemia With Intravenously Iron in Colorectal Cancer Patients.', 'organization': {'class': 'OTHER', 'fullName': 'Zealand University Hospital'}, 'officialTitle': 'Effects of Preoperative Correction of Anemia With Intravenously Iron in Colorectal Cancer Patients.', 'orgStudyIdInfo': {'id': 'REG-056-2020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Iron(III)isomaltoside 1000', 'description': 'Anemic patients receiving treatment with iron(III)isomaltoside', 'interventionNames': ['Drug: Iron(III)isomaltoside']}, {'type': 'NO_INTERVENTION', 'label': 'Historical comparison', 'description': 'Anemic patients without receiving treatment prior to surgery. Historical comparison.'}, {'type': 'NO_INTERVENTION', 'label': 'Concurrent comparison', 'description': 'Non-anemic patients not receiving treatment with iron(III)isomaltoside prior to surgery'}], 'interventions': [{'name': 'Iron(III)isomaltoside', 'type': 'DRUG', 'description': 'Individual weight and hemoglobin dependent dosage', 'armGroupLabels': ['Iron(III)isomaltoside 1000']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Rasmus D Bojesen, MD', 'role': 'CONTACT', 'email': 'radb@regionsjaelland.dk', 'phone': '+4526193789'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zealand University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}