2022-09-01
2025-03-01
2025-06-30
350
NCT05362344
University of Washington, the Collaborative Health Studies Coordinating Center
University of Washington, the Collaborative Health Studies Coordinating Center
OBSERVATIONAL
Colorectal Cancer Screening in Cystic Fibrosis
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).
NICE-CF is a cross-sectional, multi-center study comparing stool-based testing (multi-target DNA test and quantitative FIT test) to standard of care colonoscopy for colorectal cancer (CRC) screening in people with CF. The study includes an enrollment visit, two stool samples completed at home, a clinical screening colonoscopy, and three participant surveys which will be completed at enrollment or remotely. The total duration of participant participation will be 3-12 months, depending on the timing of the completion of the stool samples and the participant's colonoscopy. The targeted participant timeline is 3 months from enrollment to the completion of a clinical screening colonoscopy. To allow for varying site-specific clinical colonoscopy scheduling delays and COVID delays in scheduling, the duration of time between submitting stool samples and screening colonoscopy may extend up to 12 months for inclusion of data in the study. However, participating sites must notify the DCC to obtain preapproval for greater than 3 months duration between stool-based testing and colonoscopy. CF patients who are eligible for CRC screening will either be enrolled during an in-person CF clinic visit or via phone/video if clinic visits are taking place remotely. Participants will be asked to perform stool sample collection at home, and then complete their colonoscopy within three to twelve months of submission of the stool sample.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2022-04-28 | N/A | 2024-10-01 |
2022-05-02 | N/A | 2024-10-03 |
2022-05-05 | N/A | 2024-10 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
N/A
Allocation:
N/A
Interventional Model:
N/A
Masking:
N/A
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| : NICE-CF Cohort Adults with CF ages 18 - 75 years who are due for a routine screening or surveillance colonoscopy for colon cancer. | PROCEDURE: Stool tests
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Sensitivity of multi-target stool DNA test and quantitative fecal immunochemical (FIT) test | Negative predictive value (NPV) and sensitivity for detection of any adenomas, advanced adenomas, and CRC in stool-based testing. | 3-12 months |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Specificity of multi-target stool DNA test and quantitative fecal immunochemical (FIT) test | Specificity and positive predictive value (PPV) of stool-based testing for any adenomas, advanced adenomas, and CRC | 3-12 months |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
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