Effects of Preoperative Correction of Anemia With Intravenously Iron in Colorectal Cancer Patients.
1 other identifier
interventional
200
0 countries
N/A
Brief Summary
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. The 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. The study period of cases undergoing i.v. treatment will be 1st of February 2017 to 31st of October 2019 with approximately 70 cases included
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable colorectal-cancer
Started Mar 2022
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 14, 2021
CompletedFirst Posted
Study publicly available on registry
February 3, 2022
CompletedStudy Start
First participant enrolled
March 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2023
CompletedFebruary 3, 2022
April 1, 2021
1.8 years
April 14, 2021
January 21, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Gene expression and lymphocyte infiltration of the tumor
770 gene expression analysis and CD3/CD8+ lymphocyte infiltration of the primary tumor
1 day after surgery
Complications
Postoperative complications after surgery measured by the Clavien-Dindo classification
30 days after surgery
Secondary Outcomes (5)
Length of stay
up to 100 days
Readmission
Within 30 days after surgery
Time to chemotherapy
up to 100 days
Perioperative blood transfusions
from outpatient assesment to 30 days after surgery
Mortality
30 days, 90 days and one year
Study Arms (3)
Iron(III)isomaltoside 1000
EXPERIMENTALAnemic patients receiving treatment with iron(III)isomaltoside
Historical comparison
NO INTERVENTIONAnemic patients without receiving treatment prior to surgery. Historical comparison.
Concurrent comparison
NO INTERVENTIONNon-anemic patients not receiving treatment with iron(III)isomaltoside prior to surgery
Interventions
Individual weight and hemoglobin dependent dosage
Eligibility Criteria
You may qualify if:
- Undergoing curative intended surgery for colon or rectum cancer
- UICC stage I-III
You may not qualify if:
- Neoadjuvant oncological treatment
- Acute / subacute surgery
- Palliative surgery
- Other pathology than adenocarcinoma
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 14, 2021
First Posted
February 3, 2022
Study Start
March 1, 2022
Primary Completion
December 1, 2023
Study Completion
December 1, 2023
Last Updated
February 3, 2022
Record last verified: 2021-04