Colorectal Cancer Screening in Cystic Fibrosis

Trial ID or NCT#

NCT05362344

Status

not recruiting iconNOT RECRUITING

Purpose

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).

Official Title

A Multi-Center Study of Non-Invasive Colorectal Cancer Evaluation in Cystic Fibrosis (NICE-CF)

Eligibility Criteria

Ages Eligible for Study: 18 to 75
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. 1. Adults with CF ages 18 - 75 years and due for a routine screening or surveillance colonoscopy for colon cancer2. 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 CF3. Capable of understanding the purposes and risks of the study in English or Spanish and willing to participate and sign informed consent4. Referred for screening or surveillance colonoscopy for CRC (current standard of care) and willing to undergo colonoscopy and stool testing5. Able to access the Internet to complete self-administered surveys
    1. Exclusion Criteria:
  2. 1. Any condition that, in the opinion of the site PI, introduces undue risk by participating in this study2. Incapable of understanding the purposes of the study or informed consent for any reason3. Pregnancy4. 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 enrollment6. Symptoms that merit colonoscopy for diagnostic purposes rather than as screening for CRC7. Known history of familial colon cancer syndrome that has been confirmed by previous genetic testing
Exclusion Criteria:
  1. 1. Any condition that, in the opinion of the site PI, introduces undue risk by participating in this study2. Incapable of understanding the purposes of the study or informed consent for any reason3. Pregnancy4. 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 enrollment6. Symptoms that merit colonoscopy for diagnostic purposes rather than as screening for CRC7. Known history of familial colon cancer syndrome that has been confirmed by previous genetic testing
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Investigator(s)

Monique Barakat
Monique Barakat
Therapeutic endoscopy specialist, Gastroenterologist, Biliary specialist, Endoscopic ultrasound specialist
Associate Professor of Pediatrics (Gastroenterology) and of Medicine (Gastroenterology and Hepatology)

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Contact

Sukhada Mairal, PhD

View on ClinicalTrials.gov