Effects of Preoperative Correction of Anemia With Intravenously Iron in Colorectal Cancer Patients.
Primary Purpose
Colorectal Cancer, Anemia, Iron-deficiency
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Iron(III)isomaltoside
Sponsored by
About this trial
This is an interventional basic science trial for Colorectal Cancer focused on measuring Anemia, Iron-deficiency anemia
Eligibility Criteria
Inclusion Criteria:
- Undergoing curative intended surgery for colon or rectum cancer
- UICC stage I-III
Exclusion Criteria:
- Neoadjuvant oncological treatment
- Acute / subacute surgery
- Palliative surgery
- Other pathology than adenocarcinoma
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
No Intervention
No Intervention
Arm Label
Iron(III)isomaltoside 1000
Historical comparison
Concurrent comparison
Arm Description
Anemic patients receiving treatment with iron(III)isomaltoside
Anemic patients without receiving treatment prior to surgery. Historical comparison.
Non-anemic patients not receiving treatment with iron(III)isomaltoside prior to surgery
Outcomes
Primary Outcome Measures
Gene expression and lymphocyte infiltration of the tumor
770 gene expression analysis and CD3/CD8+ lymphocyte infiltration of the primary tumor
Complications
Postoperative complications after surgery measured by the Clavien-Dindo classification
Secondary Outcome Measures
Length of stay
Length of postoperative hospital stay, until discharge or death.
Readmission
Any readmission over 24 hours in length
Time to chemotherapy
Tme from surgery to adjuvant oncological treatment for patients with high risk stage II and stage III disease
Perioperative blood transfusions
Any blood transfusions measured in ml.
Mortality
Mortality
Full Information
NCT ID
NCT05221957
First Posted
April 14, 2021
Last Updated
January 21, 2022
Sponsor
Zealand University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05221957
Brief Title
Effects of Preoperative Correction of Anemia With Intravenously Iron in Colorectal Cancer Patients.
Official Title
Effects of Preoperative Correction of Anemia With Intravenously Iron in Colorectal Cancer Patients.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 1, 2022 (Anticipated)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zealand University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, Anemia, Iron-deficiency
Keywords
Anemia, Iron-deficiency anemia
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Propensity score matched cohort study
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Iron(III)isomaltoside 1000
Arm Type
Experimental
Arm Description
Anemic patients receiving treatment with iron(III)isomaltoside
Arm Title
Historical comparison
Arm Type
No Intervention
Arm Description
Anemic patients without receiving treatment prior to surgery. Historical comparison.
Arm Title
Concurrent comparison
Arm Type
No Intervention
Arm Description
Non-anemic patients not receiving treatment with iron(III)isomaltoside prior to surgery
Intervention Type
Drug
Intervention Name(s)
Iron(III)isomaltoside
Intervention Description
Individual weight and hemoglobin dependent dosage
Primary Outcome Measure Information:
Title
Gene expression and lymphocyte infiltration of the tumor
Description
770 gene expression analysis and CD3/CD8+ lymphocyte infiltration of the primary tumor
Time Frame
1 day after surgery
Title
Complications
Description
Postoperative complications after surgery measured by the Clavien-Dindo classification
Time Frame
30 days after surgery
Secondary Outcome Measure Information:
Title
Length of stay
Description
Length of postoperative hospital stay, until discharge or death.
Time Frame
up to 100 days
Title
Readmission
Description
Any readmission over 24 hours in length
Time Frame
Within 30 days after surgery
Title
Time to chemotherapy
Description
Tme from surgery to adjuvant oncological treatment for patients with high risk stage II and stage III disease
Time Frame
up to 100 days
Title
Perioperative blood transfusions
Description
Any blood transfusions measured in ml.
Time Frame
from outpatient assesment to 30 days after surgery
Title
Mortality
Description
Mortality
Time Frame
30 days, 90 days and one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Undergoing curative intended surgery for colon or rectum cancer
UICC stage I-III
Exclusion Criteria:
Neoadjuvant oncological treatment
Acute / subacute surgery
Palliative surgery
Other pathology than adenocarcinoma
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rasmus D Bojesen, MD
Phone
+4526193789
Email
radb@regionsjaelland.dk
12. IPD Sharing Statement
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Effects of Preoperative Correction of Anemia With Intravenously Iron in Colorectal Cancer Patients.
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