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COLO-COHORT (Colorectal Cancer Cohort) Study

ConditionsColorectal CancerColorectal AdenomaColorectal NeoplasmPredictive Cancer ModelModel
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSouth Tyneside and Sunderland NHS Foundation Trust

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

Unable to give informed consent

Known polyposis syndrome

Previous total colectomy

Known colonic stricture which would limit complete colonoscopy

Trial population

Patients who have been referred for a colonoscopy (minimum age limits as above in inclusion criteria) either through the bowel cancer screening programme, as part of a surveillance programme or due to symptoms

Trial design

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

  • Colonoscopy

    Diagnostic test

    Diagnostic colonoscopy

Treatment groups

15,000 Participants
are divided into 2 treatment groups
Group A: Group A (Cross-sectional arm)1 intervention
Group B: COLO-SPEED (Group B, consent for contact arm)1 intervention

Trial outcomes

Primary outcomes

1

Occurrence of colorectal neoplasia

Incidence of colorectal neoplasia (colorectal cancer and advanced adenomas)

Time frame
5 years

Secondary outcomes

1

Stool microbiome pattern

Assessing trends in variation of stool microbiome in patients with normal colon, adenomas, bowel cancer)

Time frame
5 years
2

Number of participants who consent for future contact

A registry of patients who consent to be contacted in the future for future research studies

Time frame
5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

South Tyneside and Sunderland NHS Foundation Trust

Lead sponsor

Newcastle University

Collaborator

Source ClinicalTrials.gov
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