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COLO-COHORT (Colorectal Cancer Cohort) Study

Sponsor: South Tyneside and Sunderland NHS Foundation Trust

NCT ID: NCT04185779

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Health checks and monitoring — no treatment given
Type of study
Observational (no treatment given)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Colonoscopy (diagnostic test)
How long the study runs
Study runs about 80 months (dates as stated)
About the drug or intervention
Colonoscopy — diagnostic test: Diagnostic colonoscopy
Patient visit burden
Not specified by the sponsor
Type of study
Observing health over time
Ages
18 Years and over
Who
All
Number of participants
15,000
Started
2019-12-13
Last checked
2020-06

Plain English Summary

What is this study?

  • • Testing a new treatment for colorectal cancer
  • • Clinical study - 15,000 participants
  • • 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

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with colorectal cancer

Where?

  • • South Shields - South Tyneside and Sunderland NHS Foundation Trust
  • • Kettering - Kettering General Hospitals NHS Foundation Trust
  • • Stockton-on-Tees - North Tees and Hartlepool NHS Foundation Trust

This is a simplified summary. Always discuss with your doctor before making any decisions.

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.

More detail

Bowel cancer is the second commonest cause of cancer death in the UK with 16000 people dying per year. Although the NHS Bowel Cancer Screening Programme (BCSP) detects cancers at an earlier stage only 10% of all cancers are detected through screening. Currently, the only criteria for screening is age and no account is taken of other known risk factors such as smoking, alcohol, family history or obesity. Stool FIT (a new stool test which detects blood that can't be seen with the naked eye) will be introduced into the English BCSP, but there is poor evidence for its use in patients presenting with symptoms. There is also emerging data that there may be differences in the gut bacteria of people with and without cancer or pre cancerous bowel polyps (adenomas). This will be a national multi-centre study over 5-years. 10000 Patients undergoing colonoscopy as part of BCSP or due to symptoms will be recruited. Patients will be asked to fill in a health questionnaire, have their height, weight, waist circumference measured. Patients will also receive blood tests, stool tests or saliva tests depending on the indication for their colonoscopy. The results of the colonoscopy and any samples taken will be collated. Patients will receive a patient experience questionnaire or food frequency questionnaire. A further 10,000 patients from the North of England will be consented to be contacted for future studies with some of the information above collected. The aim of this study is to develop a risk prediction model to help determine which patients are at highest risk of having adenomas or bowel cancer. The investigators will also explore the significance of the gut bacteria composition in patients with adenomas or cancer to help inform this risk model. Additionally the investigators will develop a large platform of patients who consent to be contacted for future research.

Colorectal CancerColorectal AdenomaColorectal NeoplasmPredictive Cancer ModelModel

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What we know so far

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

Biomarkers mentioned

FIT positive

What the study is looking for

  • ✓Group A
  • ✓Aged ≥30 years\* and able to give agreement to take part
  • ✓Patients attending colonoscopy
  • ✓Through Bowel Cancer Screening Programme (FIT positive, Bowelscope conversion, surveillance)
  • ✓(COLO-SPEED) Group B

Who cannot take part

  • ✗Group A
  • ✗Unable to give agreement to take part
  • ✗Known polyposis syndrome
  • ✗Previous total colectomy
  • ✗Known colonic stricture which would limit complete colonoscopy
See the full criteria
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)

Where Is This Study? (3 UK sites)

South Tyneside and Sunderland NHS Foundation Trust

South Shields NE34 0PL, United Kingdom

Recruiting
Site contact (verified)

Kettering General Hospitals NHS Foundation Trust

Kettering NN16 8UZ, United Kingdom

NOT_YET_RECRUITING
Site contact (verified)

North Tees and Hartlepool NHS Foundation Trust

Stockton-on-Tees TS19 8PE, United Kingdom

Recruiting
Site contact (verified)

How to Get in Touch

Sara Koo

Sponsor contact

CONTACT

0191 404 1000 sara.koo@stft.nhs.uk

Amy Burns

Sponsor contact

CONTACT

Data sourced from ClinicalTrials.gov · Last verified: 2020-06