THE SCRIPT (Snp Cancer Risk Prediction) TRIAL: A STUDY OF DNA TESTING TO TAILOR BOWEL CANCER SCREENING IN PRIMARY CARE

Not Applicable

Active, not recruiting

• Conditions: Bowel cancer; Bowel cancer screening; Cancer - Bowel - Back passage (rectum) or large bowel (colon)

• Registration Number: ACTRN12621000092897
• Lead Sponsor: The University of Melbourne

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-02-01
• Last Update Posted: 29 July 2024

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 274

Inclusion Criteria

•Eligible participants for the trial are aged between 45 and 70 years old
•Participants able to read and write English and competent to give informed consent
•Participants who are contactable over the next 12 months for the study follow-up

Inclusion restricted to patients that are potentially due for some form of bowel cancer screening within the next 12 months, i.e.:
oAll patients aged 45-50 will be, included as we will not know their genomic risk pre-recruitment. Some will be at increased risk and therefore be recommended early screening in the study;
oThose aged 50-70 years of age who report not having an FOBT in last 2 years.

Exclusion Criteria

•Patients with a previous diagnosis of colorectal cancer are excluded
•Patients with at least one grandparent was born in Africa or is of African ethnicity are ineligible to participate due to the specificity of the DNA test
•Patients with a known genetic predistortion to colorectal cancer or a family history of cancer that requires referral for assessment of a genetic predisposition to colorectal cancer are excluded (according to the NHMRC guidelines). This includes:
oThose confirmed as carrying a pathogenic mutation in a gene associated with a high-risk familial syndrome
oThose with a relative confirmed as carrying a pathogenic mutation in a gene associated with a high-risk familial syndrome, who have not themselves been tested
oThose with or those with a relative with familial adenomatous polyposis
oThose with a relative with multiple colorectal cancers
oThose with at least three first-degree or second-degree relatives with a Lynch syndrome-related cancer (colorectal, endometrial, ovarian, stomach, small bowel, renal pelvis or ureter, biliary tract, brain) with at least one diagnosed before age 55 years).

Patients with recent rectal bleeding or inflammatory bowel disease are excluded and referred for assessment by their GP because they may require colonoscopy as a diagnostic rather than screening procedure.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To measure the effect of offering a polygenic risk score for colorectal cancer risk and tailored advice (i.e. the SCRIPT intervention) on risk-appropriate colorectal cancer screening (i.e. the right screening test, FOBT or colonoscopy, based on a person’s 10-year absolute risk of colorectal cancer) compared with generic cancer prevention information.[ 12 months post-recruitment.<br>]