Colorectal Cancer Screening in Cystic Fibrosis (NCT05362344) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Colorectal Cancer Screening in Cystic Fibrosis
United States350 participantsStarted 2022-09-01
Plain-language summary
This multi-center study will compare multi-target DNA and quantitative FIT stool-based testing to colonoscopy in individuals with Cystic Fibrosis (CF) undergoing colon cancer screening with colonoscopy. The primary endpoint is detection of any adenomas, including advanced adenomas and colorectal cancer (CRC).
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Adults with CF ages 18 - 75 years and due for a routine screening or surveillance colonoscopy for colon cancer
. Cystic Fibrosis diagnosis, defined by a sweat chloride test result ≥ 60 mmol/L (may be of historic value), and/or documented CF-causing CFTR mutations and clinical features of CF
. Capable of understanding the purposes and risks of the study in English or Spanish and willing to participate and sign informed consent
. Referred for screening or surveillance colonoscopy for CRC (current standard of care) and willing to undergo colonoscopy and stool testing
. Able to access the Internet to complete self-administered surveys
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Sensitivity of multi-target stool DNA test and quantitative fecal immunochemical (FIT) test
Timeframe: 3-12 months
Trial details
NCT IDNCT05362344
SponsorUniversity of Washington, the Collaborative Health Studies Coordinating Center
. Any condition that, in the opinion of the site PI, introduces undue risk by participating in this study
. Incapable of understanding the purposes of the study or informed consent for any reason
. Pregnancy
. Active inflammatory bowel disease as defined by a prior diagnosis of Crohn's Disease or Ulcerative Colitis, based on both clinical and histopathologic findings and the individual currently on medical therapy for Crohn's disease or Ulcerative Colitis.
. Personal history of colon cancer diagnosis and treatment within 5 years of enrollment
. Symptoms that merit colonoscopy for diagnostic purposes rather than as screening for CRC
. Known history of familial colon cancer syndrome that has been confirmed by previous genetic testing