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
Protocol serial number	N/A
Sponsor	Poole Hospital NHS Foundation Trust
Funder	Poole Hospital Gastroenterology Research Fund

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 ID	0000-0002-3172-2722

Study information

Primary study design	Observational
Study design	Single-centre cohort observation
Secondary study design	Cohort study
Participant information sheet	ISRCTN18342140_PIS_21Jun16.doc
Scientific title	The role of faecal occult blood testing in risk stratification for GI malignancy in subjects with iron deficiency anaemia
Study acronym	IDIOM (3)
Study objectives	Screening 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) studied	Iron deficiency anaemia caused by gastrointestinal malignancy
Intervention	All 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 type	Other
Primary outcome measure(s)	The predictive value of immunochemical faecal blood testing for gastrointestinal malignancy
Key secondary outcome measure(s)	The predictive value of immunochemical faecal blood testing for: 1. Colorectal cancer 2. Any bleeding lesion
Completion date	30/06/2018

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	357
Total final enrolment	62
Key inclusion criteria	Confirmed iron deficiency anaemia
Key exclusion criteria	1. 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 enrolment	01/07/2016
Date of final enrolment	30/06/2018

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Poole Hospital NHS Foundation Trust

Longfleet Road
Poole
BH15 2JB
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	21/05/2020	13/07/2020	Yes	No
Participant information sheet		21/06/2016	20/09/2016	No	Yes
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
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