Colorectal Cancer Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

Part A

• People who have been diagnosed with Familial Adenomatous Polyposis (FAP) — either through genetic testing showing a faulty APC gene, through having a family member with a confirmed APC gene fault and showing signs of FAP, or through a clinical diagnosis confirmed by two specialists in gastrointestinal cancer genetics.
• People who have already had a major bowel surgery to remove most or all of the colon, specifically either a subtotal colectomy with ileorectal anastomosis (STC-IRA) or a total proctocolectomy with ileal pouch anal anastomosis (TPC-IPAA) (confirm with trial site if unsure which surgery applies).
• People who are able to give their informed consent to participate.

Part B

• People who have been diagnosed with FAP — either through genetic testing showing a faulty APC gene, through having a family member with a confirmed APC gene fault and showing signs of FAP, or through a clinical diagnosis confirmed by two specialists in gastrointestinal cancer genetics.
• People who are willing to undergo a colonoscopy or sigmoidoscopy (bowel camera examination), which may already be part of their routine care.
• People who are able to have a stomach and upper digestive tract camera examination (upper endoscopy) performed at the same time as the bowel examination, which may also already be part of their routine care.
• People who have at least two colorectal polyps (small growths in the bowel) present at the time of enrolment, anywhere in the colon, rectal area, or J-pouch if applicable.
• People who are able to give their informed consent to participate.

Who may not be able to join:

Part A

• People who are pregnant, are currently a prisoner, or are under 18 years of age.
• People who have previously had a total proctocolectomy with a permanent end ileostomy (a type of bowel surgery involving a permanent stoma bag).
• People with a history of inflammatory bowel disease (such as Crohn's disease or ulcerative colitis).
• People who have diabetes and are currently taking medication to treat it.
• People who have chronic kidney disease with reduced kidney function below a certain level (eGFR less than 60 mL/min/1.73m²) (confirm with trial site).
• People who have been diagnosed with cancer and are currently receiving active cancer treatment.
• People who have been following a ketogenic (very low carbohydrate) diet or intermittent fasting — meaning regularly fasting for 16 hours or more per day for reasons unrelated to a medical procedure — within the four weeks before enrolling.

Part B

• People who are pregnant, are currently a prisoner, or are under 18 years of age.
• People who are not medically able to undergo a colonoscopy, sigmoidoscopy, or upper endoscopy.
• People who have previously had a total proctocolectomy with a permanent end ileostomy.
• People with a history of inflammatory bowel disease (such as Crohn's disease or ulcerative colitis).
• People who have diabetes and are currently taking medication to treat it.
• People who have chronic kidney disease with reduced kidney function below a certain level (eGFR less than 60 mL/min/1.73m²) (confirm with trial site).
• People who have been diagnosed with cancer and are currently receiving active cancer treatment.
• People who have been following a ketogenic diet or intermittent fasting of 16 hours or more per day (unrelated to a medical procedure) within the four weeks before enrolling.
• People who have regularly used certain medicines or supplements in the six weeks before enrolling that are considered FAP-prevention agents — including aspirin at doses above 81mg daily, anti-inflammatory medicines (NSAIDs), beta-hydroxybutyrate (BHB) supplements, or any other agent the study team considers relevant (confirm with trial site).
• People who have a polyp larger than 1 cm found during bowel examination that has not been removed, not including polyps at a specific area near the small intestine called the ampulla (confirm with trial site).

Important: Always verify eligibility with the trial site directly before applying.