Contact information
Type
Scientific
Contact name
Dr Jonathon Snook
ORCID ID
http://orcid.org/0000-0002-3172-2722
Contact details
Poole Hospital NHS Foundation Trust
Poole
BH11 9NG
United Kingdom
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
The role of faecal occult blood testing in risk stratification for GI malignancy in subjects with iron deficiency anaemia
Acronym
IDIOM (3)
Study hypothesis
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
Study design
Single-centre cohort observation
Primary study design
Observational
Secondary study design
Cohort study
Study setting(s)
Hospital
Study type
Screening
Patient information sheet
See additional files
Condition
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
The predictive value of immunochemical faecal blood testing for gastrointestinal malignancy
Secondary outcome measures
The predictive value of immunochemical faecal blood testing for:
1. Colorectal cancer
2. Any bleeding lesion
Overall study start date
01/09/2015
Overall study end date
30/06/2018
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Confirmed iron deficiency anaemia
Participant type(s)
Patient
Age group
Adult
Sex
Both
Target number of participants
357
Total final enrolment
62
Participant 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
Recruitment start date
01/07/2016
Recruitment end date
30/06/2018
Locations
Countries of recruitment
England, United Kingdom
Study participating centre
Poole Hospital NHS Foundation Trust
Longfleet Road
Poole
BH15 2JB
United Kingdom
Sponsor information
Organisation
Poole Hospital NHS Foundation Trust
Sponsor details
Longfleet Road
Poole
BH15 2JB
England
United Kingdom
Sponsor type
Hospital/treatment centre
Website
ROR
Funders
Funder type
Hospital/treatment centre
Funder name
Poole Hospital Gastroenterology Research Fund
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Publication in a peer-reviewed journal
Intention to publish date
31/12/2020
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Available on request
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