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CompletedNCT03988712Updated Jun 20, 2019

Measures to Increase the Effectiveness of Fast Track Colorectal Clinics for Iron Deficiency Anaemia.

An observational study in Colorectal Cancer, sponsored by Wirral University Teaching Hospital NHS Trust. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-06-20.

Sponsored by Wirral University Teaching Hospital NHS Trust · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
950
Ages
18 Years and older
Sex
All
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Study 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 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.

02

Conditions studied

  • Colorectal Cancer

Keywords

  • Anaemia
  • colorectal cancer
  • Iron deficiency anaemia
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In context

Colorectal Neoplasms

5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.

This study's enrollment of 950 is above the median of 250 across 1,226 observational studies indexed under Colorectal Neoplasms.

Browse Colorectal Neoplasms studies →

Lead sponsor

Wirral University Teaching Hospital NHS Trust is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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

Inclusion criteria

  • Patients with age more than 18 years Presenting to fast track colorectal clinic
  1. With bowel symptoms
  2. Presenting with anaemia
  3. Rectal bleeding

Exclusion criteria

Exclusion Criteria:

  • Any patient presenting through routine colorectal clinics

    1. With bowel symptoms
    2. Presenting with anaemia
    3. Rectal bleeding Aged less than 18 years
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
950 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

    Diagnostic Test: Colonoscopy, gastroscopy, virtual colonoscopy, CT scan

  • Iron deficiency anaemia with no bowel symptoms

    Patients with IDA with no bowel symptoms

    Diagnostic Test: Colonoscopy, gastroscopy, virtual colonoscopy, CT scan

  • Iron deficiency anaemia with rectal bleeding

    Patients with IDA and rectal bleeding

    Diagnostic Test: Colonoscopy, gastroscopy, virtual colonoscopy, CT scan

Interventions

  • Diagnostic testColonoscopy, gastroscopy, virtual colonoscopy, CT scan

    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.

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 2 weeks

07

Study locations

1 site
  • York Hospital
    York, Yorkshire YO31 8HE, United Kingdom
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References and documents

Individual participant data

Plan to share: Undecided — I have an excel sheet of the data and statistics done on the data which can be provided on request

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 20, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03988712
Lead sponsor
Wirral University Teaching Hospital NHS Trust
Responsible party
Mr Talal Majeed (Research Fellow, Wirral University Teaching Hospital NHS Trust) — Principal investigator
First posted
Jun 17, 2019
Start date
Apr 1, 2018
Primary completion
Aug 3, 2018
Completion
Feb 12, 2019
Last update
Jun 20, 2019

Study contacts

TALAL MAJEED, MRCS
principal investigator · Mr Talal Majeed

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.

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