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
Contact information
Dr Jonathon Snook
Scientific
Scientific
Poole Hospital NHS Foundation Trust
Poole
BH11 9NG
United Kingdom
 ORCID ID |
0000-0002-3172-2722 |
|---|
Study information
| Study design | Single-centre cohort observation |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Screening |
| 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 | 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 |
| Completion date | 30/06/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 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
- England
- United Kingdom
Study participating centre
Poole Hospital NHS Foundation Trust
Longfleet Road
Poole
BH15 2JB
United Kingdom
Poole
BH15 2JB
United Kingdom
Sponsor information
Poole Hospital NHS Foundation Trust
Hospital/treatment centre
Hospital/treatment centre
Longfleet Road
Poole
BH15 2JB
England
United Kingdom
"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 date | 31/12/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Publication 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
