Colorectal CancerNCT05221957
Effects of Preoperative Correction of Anemia With Intravenously Iron in Colorectal Cancer Patients.
A study testing Iron(III)isomaltoside in people with Colorectal Cancer and Anemia, run by Zealand University Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Anemia, Iron-deficiency
- What is being tested?
- Iron(III)isomaltoside
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2022to Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Undergoing curative intended surgery for colon or rectum cancer
- UICC stage I-III
Who cannot join
- Neoadjuvant oncological treatment
- Acute / subacute surgery
- Palliative surgery
- Other pathology than adenocarcinoma
Trial locations and contacts
No sites are listed yet.
About this study
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
- Conditions
- Colorectal Cancer, Anemia, Iron-deficiency
- Being tested
- Iron(III)isomaltoside
- Keywords
- Anemia, Iron-deficiency anemia
- Medical subject headings
- Colorectal Neoplasms, Anemia, Anemia, Iron-Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iron(III)isomaltosideDrug
Individual weight and hemoglobin dependent dosage
| Study group | Role | What they receive |
|---|---|---|
| Iron(III)isomaltoside 1000 | Experimental | Anemic patients receiving treatment with iron(III)isomaltoside Receives: Drug: Iron(III)isomaltoside |
| Historical comparison | No intervention | Anemic patients without receiving treatment prior to surgery. Historical comparison. |
| Concurrent comparison | No intervention | Non-anemic patients not receiving treatment with iron(III)isomaltoside prior to surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gene expression and lymphocyte infiltration of the tumor
770 gene expression analysis and CD3/CD8+ lymphocyte infiltration of the primary tumor
Measured: 1 day after surgery
Complications
Postoperative complications after surgery measured by the Clavien-Dindo classification
Measured: 30 days after surgery
Secondary outcomes (5)
Length of stay
Length of postoperative hospital stay, until discharge or death.
Measured: up to 100 days
Readmission
Any readmission over 24 hours in length
Measured: Within 30 days after surgery
Time to chemotherapy
Tme from surgery to adjuvant oncological treatment for patients with high risk stage II and stage III disease
Measured: up to 100 days
Perioperative blood transfusions
Any blood transfusions measured in ml.
Measured: from outpatient assesment to 30 days after surgery
Mortality
Mortality
Measured: 30 days, 90 days and one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2022
- Study start1 Mar 2022 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Zealand University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Propensity score matched cohort study
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zealand University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05221957
- Sponsor's protocol ID
- REG-056-2020
- Status last verified
- Apr 2021
- First submitted
- 14 Apr 2021
- Last updated
- 3 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Preoperative Correction of Anemia With Intravenously Iron in Colorectal Cancer Patients.
- ClinicalTrials.gov ID
- NCT05221957
- Acronym / sponsor ID
- REG-056-2020
- Conditions
- Colorectal Cancer, Anemia, Iron-deficiency
- Keywords
- Anemia, Iron-deficiency anemia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Zealand University HospitalUniversity, hospital or other
- Study start
- 1 Mar 2022 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 3 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Propensity score matched cohort study
| Arm | Type | Receives |
|---|---|---|
| Iron(III)isomaltoside 1000 | Experimental | Drug: Iron(III)isomaltosideAnemic patients receiving treatment with iron(III)isomaltoside |
| Historical comparison | No intervention | –Anemic patients without receiving treatment prior to surgery. Historical comparison. |
| Concurrent comparison | No intervention | –Non-anemic patients not receiving treatment with iron(III)isomaltoside prior to surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Undergoing curative intended surgery for colon or rectum cancer
- UICC stage I-III
Key exclusion criteria (4 listed)
- Neoadjuvant oncological treatment
- Acute / subacute surgery
- Palliative surgery
- Other pathology than adenocarcinoma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Iron(III)isomaltosideIndividual weight and hemoglobin dependent dosage | Drug | Iron(III)isomaltoside 1000 |
Primary outcome
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
Complications
Time frame: 30 days after surgery
Postoperative complications after surgery measured by the Clavien-Dindo classification
5 secondary outcomes
Length of stay
Time frame: up to 100 days
Readmission
Time frame: Within 30 days after surgery
Time to chemotherapy
Time frame: up to 100 days
Perioperative blood transfusions
Time frame: from outpatient assesment to 30 days after surgery
Mortality
Time frame: 30 days, 90 days and one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Iron(III)isomaltoside in people with Colorectal Cancer and Anemia, run by Zealand University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rasmus D Bojesen, MD (+4526193789, radb@regionsjaelland.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gene expression and lymphocyte infiltration of the tumor (time frame: 1 day after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2022.