Effects of Preoperative Correction of Anemia With Intravenously Iron in Colorectal Cancer Patients.

January 21, 2022 updated by: Zealand University Hospital

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Iron(III)isomaltoside 1000
Anemic patients receiving treatment with iron(III)isomaltoside
Drug: Iron(III)isomaltoside
Individual weight and hemoglobin dependent dosage
No Intervention: Historical comparison
Anemic patients without receiving treatment prior to surgery. Historical comparison.
No Intervention: Concurrent comparison
Non-anemic patients not receiving treatment with iron(III)isomaltoside prior to surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gene expression and lymphocyte infiltration of the tumor
Time Frame: 1 day after surgery
770 gene expression analysis and CD3/CD8+ lymphocyte infiltration of the primary tumor
1 day after surgery
Complications
Time Frame: 30 days after surgery
Postoperative complications after surgery measured by the Clavien-Dindo classification
30 days after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of stay
Time Frame: up to 100 days
Length of postoperative hospital stay, until discharge or death.
up to 100 days
Readmission
Time Frame: Within 30 days after surgery
Any readmission over 24 hours in length
Within 30 days after surgery
Time to chemotherapy
Time Frame: up to 100 days
Tme from surgery to adjuvant oncological treatment for patients with high risk stage II and stage III disease
up to 100 days
Perioperative blood transfusions
Time Frame: from outpatient assesment to 30 days after surgery
Any blood transfusions measured in ml.
from outpatient assesment to 30 days after surgery
Mortality
Time Frame: 30 days, 90 days and one year
Mortality
30 days, 90 days and one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zealand University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2022

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

April 14, 2021

First Submitted That Met QC Criteria

January 21, 2022

First Posted (Actual)

February 3, 2022

Study Record Updates

Last Update Posted (Actual)

February 3, 2022

Last Update Submitted That Met QC Criteria

January 21, 2022

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REG-056-2020

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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