Clinical trial · Observational
COLO-COHORT (Colorectal Cancer Cohort) Study
NCT04185779CI-TRIAL-00047858unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a cross-sectional study aimed at identifying factors which best predicts patients at high risk of colorectal cancer or colorectal adenomas and to develop a risk prediction model.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Adenoma | Colorectal Adenoma | ONTOLOGY_EXACT | 0.98 |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Colorectal Neoplasm | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Model | — | UNRESOLVED | — |
| Predictive Cancer Model | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Colonoscopy | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Group A (Cross-sectional arm)
- description
- This group will comprise of 10,000 patients who have been referred for a colonoscopy. We will be collecting information on their past medical history, smoking history, alcohol history, medication history and family history in addition to their colonoscopy findings. In 6000 of these patients, they will have blood tests, Faecal Immunochemical Test (FIT) level, blood or saliva for DNA extraction and stool microbiome taken. In 4000 of these patients, we will record recent blood tests of interest and they will have no new samples taken. All 10000 patients will also either complete a food frequency questionnaire or endoscopy patient experience questionnaire.
- interventionNames
- Diagnostic Test: Colonoscopy
- label
- COLO-SPEED (Group B, consent for contact arm)
- description
- This will be 10,000 patients who will consent for future contact for future research studies.
- interventionNames
- Diagnostic Test: Colonoscopy
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria:
Group A
* Aged ≥30 years\* and able to give informed consent
* Patients attending colonoscopy
* Through Bowel Cancer Screening Programme (FIT positive, Bowelscope conversion, surveillance)
* Through standard NHS care (most commonly due to iron deficiency anaemia, altered bowel habit, weight loss, rectal bleeding, planned polypectomy\*\*, those referred on basis of family history, abnormal cross-sectional imaging, polyp surveillance or post CRC surveillance)
* The age of 30 was chosen to ensure that this is a population likely to be enriched for colorectal neoplasia with neoplasia below this age uncommon \*\*In those attending for planned polypectomy, the results from the initial colonoscopy and the endoscopy where the polypectomy is undertaken will be summated for purposes of calculating the neoplasia profile
(COLO-SPEED) Group B
* Any patient attending for colonoscopy and able to give informed consent
* ≥ 18 years old
* Patient from the North of England
Exclusion Criteria:
Group A
* Unable to give informed consent
* Known polyposis syndrome
* Previous total colectomy
* Known colonic stricture which would limit complete colonoscopy
* Attending for planned therapeutic procedure other than polypectomy, such as insertion of colonic stent
* Attending for assessment of known inflammatory bowel disease (IBD) activity or for IBD surveillance
* Patients currently recruited into an interventional CTIMP for CRC prevention\*
COLO-SPEED (Group B) \*\*
* Unable to give informed consent
* Not in a centre supported by COLO-SPEED infrastructure (North of England)References
Publications (0)
Data not yet available
No reference posted for this study.