Condition category
Cancer
Date applied
17/06/2016
Date assigned
15/09/2016
Last edited
24/11/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Lay summary under review with external organisation

Trial website

Contact information

Type

Scientific

Primary contact

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 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

Not provided at time of registration

Study design

Single-centre cohort observation

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial 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

Phase

Drug names

Primary outcome measures

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 trial start date

01/09/2015

Overall trial end date

30/06/2018

Reason abandoned

Eligibility

Participant inclusion criteria

Confirmed iron deficiency anaemia

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

357

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

United Kingdom

Trial participating centre

Poole Hospital NHS Foundation Trust
Longfleet Road
Poole
BH15 2JB

Sponsor information

Organisation

Poole Hospital NHS Foundation Trust

Sponsor details

Longfleet Road
Poole
BH15 2JB
United Kingdom

Sponsor type

Hospital/treatment centre

Website

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

30/06/2019

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

24/11/2016: Internal review. 20/09/2016: Participant information sheet uploaded