Symptomatic FIT for Colon Cancer Detection, a Pilot Study
Key facts
- Where
- La Jolla, Egyesült ÁllamokSee the site
Where in Egyesült Államok
- Moores Cancer Center, University of California, San DiegoLa Jolla, Egyesült ÁllamokNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University of California, San Diego
- Trial code
- NCT07927270
- Record updated
- 2026. november 10.
- Original description
This pilot study will assess whether a larger study of stool testing for colorectal cancer is practical. It plans to enroll 40 adults born in 1960 or later who have new symptoms that could be related to colorectal cancer. Participants will collect a stool sample at home using a fecal immunochemical test (FIT), complete a questionnaire, and undergo blood tests and colonoscopy as part of their usual medical care. Researchers will compare research FIT results with colonoscopy findings and assess recruitment, sample collection, and completion of study activities. Research FIT results will not routinely be shared with participants or their clinicians. If a research FIT result is abnormal and colonoscopy has not been completed within six months, the study team will notify the primary care provider to encourage colonoscopy follow-up.Read full original descriptionShow less
This pilot study will assess whether a larger study of stool testing for colorectal cancer is practical. It plans to enroll 40 adults born in 1960 or later who have new symptoms that could be related to colorectal cancer. Participants will collect a stool sample at home using a fecal immunochemical test (FIT), complete a questionnaire, and undergo blood tests and colonoscopy as part of their usual medical care. Researchers will compare research FIT results with colonoscopy findings and assess recruitment, sample collection, and completion of study activities. Research FIT results will not routinely be shared with participants or their clinicians. If a research FIT result is abnormal and colonoscopy has not been completed within six months, the study team will notify the primary care provider to encourage colonoscopy follow-up.
Inclusion: Adults 18 years or older, born in 1960 or later; Newly reported signs or symptoms potentially consistent with colorectal cancer: hematochezia, persistent abdominal pain, altered bowel habits (constipation, diarrhea, or narrow stools), unintentional weight loss greater than 5 pounds, or iron deficiency anemia. Symptoms must not have been reported to the primary care provider before the index visit.
Exclusion: Prior colorectal cancer, colorectal resection, hereditary colorectal cancer syndrome (including Lynch syndrome or familial adenomatous polyposis), or inflammatory bowel disease; Up-to-date colorectal cancer screening: colonoscopy within 10 years, sigmoidoscopy within 5 years, FIT within 1 year, or multitarget stool DNA/RNA or cell-free DNA testing within 3 years; Acute symptoms within 14 days requiring urgent evaluation; Documented infectious cause that clinically explains the symptoms. A negative infectious workup or absence of an infectious workup does not exclude participation; Pregnancy; Lack of health insurance for usual-care procedures.