The role of faecal occult blood testing in identifying subjects with iron deficiency anaemia who have underlying gastro-intestinal cancer

ISRCTN ISRCTN18342140
DOI https://doi.org/10.1186/ISRCTN18342140
Secondary identifying numbers N/A
Submission date
17/06/2016
Registration date
15/09/2016
Last edited
16/05/2023
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-study-looking-whether-testing-poo-blood-can-show-who-might-be-at-risk-cancer-stomach-bowel

Contact information

Dr Jonathon Snook
Scientific

Poole Hospital NHS Foundation Trust
Poole
BH11 9NG
United Kingdom

ORCiD logoORCID ID 0000-0002-3172-2722

Study information

Study designSingle-centre cohort observation
Primary study designObservational
Secondary study designCohort study
Study setting(s)Hospital
Study typeScreening
Participant information sheet ISRCTN18342140_PIS_21Jun16.doc
Scientific titleThe role of faecal occult blood testing in risk stratification for GI malignancy in subjects with iron deficiency anaemia
Study acronymIDIOM (3)
Study objectivesScreening patients with iron deficiency anaemia by means of faecal occult blood testing can identify sub-groups at high risk of underlying gastro-intestinal malignancy, over and above the stratification provided by established clinical criteria.
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedIron deficiency anaemia caused by gastrointestinal malignancy
InterventionAll patients in the study will have a qualitative immunochemical stool test for occult blood prior to gastro-intestinal investigation of the cause of their anaemia.

All patients will be followed up until they have completed investigation of their iron deficiency anaemia, as clinically indicated. The study will assess whether faecal occult blood (FOB) testing at presentation can predict the likelihood of underlying gastrointestinal pathology in subjects with iron deficiency anaemia (IDA) and, in particular, cancer.
Intervention typeOther
Primary outcome measureThe predictive value of immunochemical faecal blood testing for gastrointestinal malignancy
Secondary outcome measuresThe predictive value of immunochemical faecal blood testing for:
1. Colorectal cancer
2. Any bleeding lesion
Overall study start date01/09/2015
Completion date30/06/2018

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants357
Total final enrolment62
Key inclusion criteriaConfirmed iron deficiency anaemia
Key exclusion criteria1. Aged under 18
2. Lack of capacity to provide informed consent and to undertake stool collection
3. Decision not to undergo investigation to establish the cause of iron deficiency
Date of first enrolment01/07/2016
Date of final enrolment30/06/2018

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Poole Hospital NHS Foundation Trust
Longfleet Road
Poole
BH15 2JB
United Kingdom

Sponsor information

Poole Hospital NHS Foundation Trust
Hospital/treatment centre

Longfleet Road
Poole
BH15 2JB
England
United Kingdom

ROR logo "ROR" https://ror.org/03kdm3q80

Funders

Funder type

Hospital/treatment centre

Poole Hospital Gastroenterology Research Fund

No information available

Results and Publications

Intention to publish date31/12/2020
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planPublication in a peer-reviewed journal
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Participant information sheet 21/06/2016 20/09/2016 No Yes
Results article results 21/05/2020 13/07/2020 Yes No
Plain English results 16/05/2023 No Yes

Additional files

ISRCTN18342140_PIS_21Jun16.doc
Uploaded 20/09/2016

Editorial Notes

16/05/2023: Cancer Research UK plain English results link added.
13/07/2020: Publication reference added.
09/12/2019: The following changes have been made:
1. The intention to publish date has been changed from 30/06/2019 to 31/12/2020.
2. The total final enrolment number has been added.
13/06/2018: Cancer Research UK lay summary link added to plain English summary field
14/05/2018: Internal review.
16/01/2018: Internal review.
16/10/2017: Internal review.
20/09/2016: Participant information sheet uploaded