Iron-deficiencyNCT04749589
Fatigue, Quality of Life, Cognitive Function and Physical Ability in Patients Suspected of Colorectal Malignancy
An observational study of Iron-deficiency and Iron Deficiency Anemia, run by Esbjerg Hospital - University Hospital of Southern Denmark at 3 sites in Denmark.
Trial summary
The aim is to investigate if iron deficiency at the time of colorectal cancer diagnosis has an influence on fatigue, quality of life, cognition and physical ability. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Iron-deficiency, Iron Deficiency Anemia, Colorectal Cancer
- What is being tested?
- iron deficiency
- How many people
- 200 participants
- Where
- 3 sitesDenmark
- Study dates
- 11 Feb 2021to 31 May 2023
- Phase
- Observational
- 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
Study population: see inclusion criteria
Who may be able to join
- patients in whom endoscopy has raised suspicion of colorectal malignancy
Who cannot join
- non fluent in Danish language
- cerebral impairment (ex severe dementia) so that informed consent can not be obtained
Trial locations and contacts
3 sites in 1 country.
Denmark3 sites
Sygehus Sønderjylland
Aabenraa, Region Syddanmark, 6200
Hospital of South West Jutland
Esbjerg, Region Syddanmark, 6700
Hospital of South West Jutland
Grindsted, Region Syddanmark, 7200
About this study
The aim is to investigate if iron deficiency at the time of colorectal cancer diagnosis has an influence on fatigue, quality of life, cognition and physical ability.
Read the detailed description
Around 60% of newly diagnosed colorectal cancer patients suffer from iron deficiency at the time of diagnosis. The study hypothesis is that, besides leading to anemia, iron deficiency might be associated with impaired patient report outcomes in the domains of fatigue, quality of life, cognitive impairment and lower physical ability. No previous studies on colorectal cancer patients and iron deficiency are available.
The participants (patients suspected of colorectal cancer after endoscopy) will be tested on these parameters. The participants and the investigators are blinded to the patients iron status. The study takes place before any preoperative iron treatment. Multivariate analysis will be used taking into account, gender, age, hemoglobin, tumor stage.
- Conditions
- Iron-deficiency, Iron Deficiency Anemia, Colorectal Cancer, Fatigue, Quality of Life, Cognitive Impairment
- Being tested
- iron deficiency
- Medical subject headings
- Anemia, Iron-Deficiency, Colorectal Neoplasms, Fatigue, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iron deficiencyDiagnostic test
Its not an intervention. Its an observational study. The groups are defined based on their iron status
| Study group | Role | What they receive |
|---|---|---|
| iron deficient | ferritin<30 or Transferine saturation<.2 Receives: Diagnostic Test: iron deficiency | |
| iron replete | opposite of the other group Receives: Diagnostic Test: iron deficiency |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue
Fatigue sub-scale of Focussed assessment of cancer treatment - anemia
Measured: up to one months after inclusion
Secondary outcomes (5)
Quality of life
European Organisation for Research and Treatment of Cancer C30
Measured: up to one months after inclusion
Cognitive ability
Montreal cognitive assessment
Measured: up to one months after inclusion
endurance
6 minutes walk test
Measured: up to one months after inclusion
peripheral muscular strengths
hand-held dynamometer
Measured: up to one months after inclusion
mobility and balance
timed-up-and-go-test
Measured: up to one months after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2021
- Study start11 Feb 2021
- Primary completion31 May 2023
- Study completion31 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iron-deficiencyStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Esbjerg Hospital - University Hospital of Southern Denmark
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Torben Knudsen, ass. prof, Study director, Institute of regional health research, regional of southern denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04749589
- Sponsor's protocol ID
- 21 6250
- Status last verified
- Aug 2023
- First submitted
- 29 Jan 2021
- Last updated
- 9 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fatigue, Quality of Life, Cognitive Function and Physical Ability in Patients Suspected of Colorectal Malignancy
- ClinicalTrials.gov ID
- NCT04749589
- Acronym / sponsor ID
- 21 6250
- Conditions
- Iron-deficiency, Iron Deficiency Anemia, Colorectal Cancer, Fatigue, Quality of Life, Cognitive Impairment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Esbjerg Hospital - University Hospital of Southern DenmarkUniversity, hospital or other
- Study start
- 11 Feb 2021 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 11 Feb 2021 (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 is to investigate if iron deficiency at the time of colorectal cancer diagnosis has an influence on fatigue, quality of life, cognition and physical ability.
Detailed description
Around 60% of newly diagnosed colorectal cancer patients suffer from iron deficiency at the time of diagnosis. The study hypothesis is that, besides leading to anemia, iron deficiency might be associated with impaired patient report outcomes in the domains of fatigue, quality of life, cognitive impairment and lower physical ability. No previous studies on colorectal cancer patients and iron deficiency are available.
The participants (patients suspected of colorectal cancer after endoscopy) will be tested on these parameters. The participants and the investigators are blinded to the patients iron status. The study takes place before any preoperative iron treatment. Multivariate analysis will be used taking into account, gender, age, hemoglobin, tumor stage.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| iron deficient | – | Diagnostic Test: iron deficiencyferritin<30 or Transferine saturation<.2 |
| iron replete | – | Diagnostic Test: iron deficiencyopposite of the other group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- see inclusion criteria
Key inclusion criteria (1 listed)
- patients in whom endoscopy has raised suspicion of colorectal malignancy
Key exclusion criteria (2 listed)
- non fluent in Danish language
- cerebral impairment (ex severe dementia) so that informed consent can not be obtained
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 deficiencyIts not an intervention. Its an observational study. The groups are defined based on their iron status | Diagnostic test | iron deficient, iron replete |
Primary outcome
Fatigue
Time frame: up to one months after inclusion
Fatigue sub-scale of Focussed assessment of cancer treatment - anemia
5 secondary outcomes
Quality of life
Time frame: up to one months after inclusion
Cognitive ability
Time frame: up to one months after inclusion
endurance
Time frame: up to one months after inclusion
peripheral muscular strengths
Time frame: up to one months after inclusion
mobility and balance
Time frame: up to one months after inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2023.
- Individual participant dataSharing planned: No
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Iron Absorption, Iron Deficiencies
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The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life
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RecruitingPhase 4
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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.
Torben Knudsen, ass. prof study director
Institute of regional health research, regional of southern denmark
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Iron-deficiency and Iron Deficiency Anemia, run by Esbjerg Hospital - University Hospital of Southern Denmark at 3 sites in Denmark.
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 1 inclusion and 2 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: finished, as of the sponsor's last update on 9 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue (time frame: up to one months after inclusion). 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 9 Aug 2023.