Clinical trial · Observational
Colorectal Cancer Screening in Cystic Fibrosis
A Multi-Center Study of Non-Invasive Colorectal Cancer Evaluation in Cystic Fibrosis (NICE-CF)
NCT05362344CI-TRIAL-00106375NICE-CFactive not recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenoma | Adenoma | ONTOLOGY_EXACT | 0.98 |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Cystic Fibrosis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Stool tests | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- NICE-CF Cohort
- description
- Adults with CF ages 18 - 75 years who are due for a routine screening or surveillance colonoscopy for colon cancer.
- interventionNames
- Procedure: Stool tests
Primary outcomes (1)
- measure
- Sensitivity of multi-target stool DNA test and quantitative fecal immunochemical (FIT) test
- timeFrame
- 3-12 months
- description
- Negative predictive value (NPV) and sensitivity for detection of any adenomas, advanced adenomas, and CRC in stool-based testing.
Secondary outcomes (1)
- measure
- Specificity of multi-target stool DNA test and quantitative fecal immunochemical (FIT) test
- timeFrame
- 3-12 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Adults with CF ages 18 - 75 years and due for a routine screening or surveillance colonoscopy for colon cancer 2. 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 3. Capable of understanding the purposes and risks of the study in English or Spanish and willing to participate and sign informed consent 4. Referred for screening or surveillance colonoscopy for CRC (current standard of care) and willing to undergo colonoscopy and stool testing 5. Able to access the Internet to complete self-administered surveys Exclusion Criteria: 1. Any condition that, in the opinion of the site PI, introduces undue risk by participating in this study 2. Incapable of understanding the purposes of the study or informed consent for any reason 3. Pregnancy 4. 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. 5. Personal history of colon cancer diagnosis and treatment within 5 years of enrollment 6. Symptoms that merit colonoscopy for diagnostic purposes rather than as screening for CRC 7. Known history of familial colon cancer syndrome that has been confirmed by previous genetic testing
References
Publications (1)
- DERIVEDHachem C, Tressel W, Hinckley Stukovsky KD, Joyeux CN, Schwarzenberg SJ, Freedman SD. A multi-center study of non-invasive colorectal cancer evaluation in cystic fibrosis (NICE-CF). J Cyst Fibros. 2026 Jun 5:S1569-1993(26)01640-1. doi: 10.1016/j.jcf.2026.05.017. Online ahead of print. PMID 42248729