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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
Zealand University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Colorectal Cancer focused on measuring Anemia, Iron-deficiency anemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    April 14, 2021
    Last Updated
    January 21, 2022
    Sponsor
    Zealand University Hospital
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    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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