Colorectal CancerNCT03988712
Measures to Increase the Effectiveness of Fast Track Colorectal Clinics for Iron Deficiency Anaemia.
An observational study of Colorectal Cancer, run by Wirral University Teaching Hospital NHS Trust at 1 site in United Kingdom.
Trial summary
A retrospective cohort study was conducted from 2016-18 in a single busy district general hospital providing services to a population of 700,000 people. In the study, patients with true IDA (low MCV and ferritin) were found to be more likely to have Colorectal cancer compared to any other type of anaemia which… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Colonoscopy, gastroscopy, virtual colonoscopy, CT scan
- How many people
- 950 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Apr 2018to 12 Feb 2019
- 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: This was a retrospective observational study from a busy district general hospital. A retrospective analysis of prospectively maintained data for FT CRC was performed. Data was selected from 2016-18. A cohort of 4177 patients presented to FT clinics. Among them 950 (22.74%) patients were referred with anaemia
Who may be able to join
- Patients with age more than 18 years Presenting to fast track colorectal clinic
- With bowel symptoms
- Presenting with anaemia
- Rectal bleeding
Who cannot join
- Any patient presenting through routine colorectal clinics
- With bowel symptoms
- Presenting with anaemia
- Rectal bleeding Aged less than 18 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Establishing Absolute Iron Deficiency Anaemia Before Referring Patients to Colorectal Fast Track Clinics Can Help to Increase the Diagnostic Yield of the Bowel Cancer Screening Programme.
A retrospective cohort study was conducted from 2016-18 in a single busy district general hospital providing services to a population of 700,000 people.
In the study, patients with true IDA (low MCV and ferritin) were found to be more likely to have Colorectal cancer compared to any other type of anaemia which confirmed the latest guidelines for management of IDA. Compared to symptoms, only the presence of a mass on abdominal examination and rectal examination was found to be more likely associated with cancer.
Read the detailed description
Although there are strict and specific guidelines for referring patients with iron deficiency anaemia (IDA) to fast track colorectal cancer (FT CRC) clinics for further assessment and investigation, patients with other types of anaemia are still referred by primary care physicians in the UK. Investigators aim was to find out whether this practice is correct, or if it is causing an overburden on colorectal clinics and endoscopy services. Investigators also want to find out whether true/absolute IDA has a higher predictive value for diagnosing colorectal cancer (CRC) compared to other types of anaemia and specific bowel symptoms.
Investigator's hypothesis was that patients with IDA are more likely to have CRC compared to patients with no anaemia or non-IDA anaemia. By confirming this hypothesis, Investigators can identify high risk patients from the population who can then be preferentially subjected to investigations mandated by guidelines. This strategy can help to increase the diagnostic yield of FT CRC clinics.
A retrospective cohort study was conducted from 2016-18 in a single busy district general hospital providing services to a population of 700,000 people.
In the study, patients with true IDA (low MCV and ferritin) were found to be more likely to have CRC compared to any other type of anaemia which confirmed the latest guidelines for management of IDA. Compared to symptoms, only the presence of a mass on abdominal examination and rectal examination was found to be more likely associated with cancer.
Physicians should be able to stratify patients based on blood indices when referring them to FT CRC clinics. Diagnostic yield of these clinics can be increased if clinicians strictly adhere to fast track guidelines and confirm true IDA before referring patients to clinic.
- Conditions
- Colorectal Cancer
- Being tested
- Colonoscopy, gastroscopy, virtual colonoscopy, CT scan
- Keywords
- Anaemia, colorectal cancer, Iron deficiency anaemia
- 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.
Colonoscopy, gastroscopy, virtual colonoscopy, CT scanDiagnostic test
Patients referred with a suspected bowel malignancy were subjected to top and bottom endoscopic examination or a cross sectional imaging like CT scan and MRI scan.
| Study group | Role | What they receive |
|---|---|---|
| Iron deficiency anaemia with bowel symptoms | Patients with IDA presenting with bowel symptoms like change in bowel habits, weight loss and abdominal mass other than rectal bleed Receives: Diagnostic Test: Colonoscopy, gastroscopy, virtual colonoscopy, CT scan | |
| Iron deficiency anaemia with no bowel symptoms | Patients with IDA with no bowel symptoms Receives: Diagnostic Test: Colonoscopy, gastroscopy, virtual colonoscopy, CT scan | |
| Iron deficiency anaemia with rectal bleeding | Patients with IDA and rectal bleeding Receives: Diagnostic Test: Colonoscopy, gastroscopy, virtual colonoscopy, CT scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic yield of colorectal cancer
diagnostic yield of colorectal cancer in patients presenting to fast track clinics with symptomatic ,asymptomatic anaemia, anaemia with normal blood indices, anaemia with Iron deficiency anaemia and certain bowel symptoms was measured. Patients were subjected to endoscopy for diagnosis. Diagnostic yield was expressed as diagnostic odds ratio and measured by statistical tools like Mantel Haenszel trend test and results are illustrated in the from of odds ratio. Crude odds ratio could not be used as association of binary outcome (colorectal caner or no cancer) with binary predictors in multiple case control groups was assessed.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2019
- Study start1 Apr 2018
- Primary completion3 Aug 2018
- Study completion12 Feb 2019
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.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 950 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wirral University Teaching Hospital NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mr Talal Majeed, Wirral University Teaching Hospital NHS Trust
- Investigators
- TALAL MAJEED, MRCS, Principal investigator, Mr Talal Majeed
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03988712
- Sponsor's protocol ID
- 161130
- Status last verified
- Jun 2019
- First submitted
- 6 Jun 2019
- Last updated
- 20 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: I have an excel sheet of the data and statistics done on the data which can be provided on request
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishing Absolute Iron Deficiency Anaemia Before Referring Patients to Colorectal Fast Track Clinics Can Help to Increase the Diagnostic Yield of the Bowel Cancer Screening Programme.
- ClinicalTrials.gov ID
- NCT03988712
- Acronym / sponsor ID
- 161130
- Conditions
- Colorectal Cancer
- Keywords
- Anaemia, colorectal cancer, Iron deficiency anaemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 950 participants (actual)
- Lead sponsor
- Wirral University Teaching Hospital NHS TrustUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 3 Aug 2018 (actual)
- Study completion
- 12 Feb 2019 (actual)
- First posted
- 17 Jun 2019 (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.
A retrospective cohort study was conducted from 2016-18 in a single busy district general hospital providing services to a population of 700,000 people.
In the study, patients with true IDA (low MCV and ferritin) were found to be more likely to have Colorectal cancer compared to any other type of anaemia which confirmed the latest guidelines for management of IDA. Compared to symptoms, only the presence of a mass on abdominal examination and rectal examination was found to be more likely associated with cancer.
Detailed description
Although there are strict and specific guidelines for referring patients with iron deficiency anaemia (IDA) to fast track colorectal cancer (FT CRC) clinics for further assessment and investigation, patients with other types of anaemia are still referred by primary care physicians in the UK. Investigators aim was to find out whether this practice is correct, or if it is causing an overburden on colorectal clinics and endoscopy services. Investigators also want to find out whether true/absolute IDA has a higher predictive value for diagnosing colorectal cancer (CRC) compared to other types of anaemia and specific bowel symptoms.
Investigator's hypothesis was that patients with IDA are more likely to have CRC compared to patients with no anaemia or non-IDA anaemia. By confirming this hypothesis, Investigators can identify high risk patients from the population who can then be preferentially subjected to investigations mandated by guidelines. This strategy can help to increase the diagnostic yield of FT CRC clinics.
A retrospective cohort study was conducted from 2016-18 in a single busy district general hospital providing services to a population of 700,000 people.
In the study, patients with true IDA (low MCV and ferritin) were found to be more likely to have CRC compared to any other type of anaemia which confirmed the latest guidelines for management of IDA. Compared to symptoms, only the presence of a mass on abdominal examination and rectal examination was found to be more likely associated with cancer.
Physicians should be able to stratify patients based on blood indices when referring them to FT CRC clinics. Diagnostic yield of these clinics can be increased if clinicians strictly adhere to fast track guidelines and confirm true IDA before referring patients to clinic.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Iron deficiency anaemia with bowel symptoms | – | Diagnostic Test: Colonoscopy, gastroscopy, virtual colonoscopy, CT scanPatients with IDA presenting with bowel symptoms like change in bowel habits, weight loss and abdominal mass other than rectal bleed |
| Iron deficiency anaemia with no bowel symptoms | – | Diagnostic Test: Colonoscopy, gastroscopy, virtual colonoscopy, CT scanPatients with IDA with no bowel symptoms |
| Iron deficiency anaemia with rectal bleeding | – | Diagnostic Test: Colonoscopy, gastroscopy, virtual colonoscopy, CT scanPatients with IDA and rectal bleeding |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This was a retrospective observational study from a busy district general hospital. A retrospective analysis of prospectively maintained data for FT CRC was performed. Data was selected from 2016-18. A cohort of 4177 patients presented to FT clinics. Among them 950 (22.74%) patients were referred with anaemia
Key inclusion criteria (4 listed)
- Patients with age more than 18 years Presenting to fast track colorectal clinic
- With bowel symptoms
- Presenting with anaemia
- Rectal bleeding
Key exclusion criteria (4 listed)
- Any patient presenting through routine colorectal clinics
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 |
|---|---|---|
| Colonoscopy, gastroscopy, virtual colonoscopy, CT scanPatients referred with a suspected bowel malignancy were subjected to top and bottom endoscopic examination or a cross sectional imaging like CT scan and MRI scan. | Diagnostic test | Iron deficiency anaemia with bowel symptoms, Iron deficiency anaemia with no bowel symptoms, Iron deficiency anaemia with rectal bleeding |
Primary outcome
Diagnostic yield of colorectal cancer
Time frame: 2 weeks
diagnostic yield of colorectal cancer in patients presenting to fast track clinics with symptomatic ,asymptomatic anaemia, anaemia with normal blood indices, anaemia with Iron deficiency anaemia and certain bowel symptoms was measured. Patients were subjected to endoscopy for diagnosis. Diagnostic yield was expressed as diagnostic odds ratio and measured by statistical tools like Mantel Haenszel trend test and results are illustrated in the from of odds ratio. Crude odds ratio could not be used as association of binary outcome (colorectal caner or no cancer) with binary predictors in multiple case control groups was assessed.
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 20 Jun 2019.
- Individual participant dataSharing planned: Undecided. I have an excel sheet of the data and statistics done on the data which can be provided on request
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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.
TALAL MAJEED, MRCS principal investigator
Mr Talal Majeed
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer, run by Wirral University Teaching Hospital NHS Trust at 1 site in United Kingdom.
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 4 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: finished, as of the sponsor's last update on 20 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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?
Diagnostic yield of colorectal cancer (time frame: 2 weeks). 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 20 Jun 2019.