Colon Cancer Clinical Trial

Colorectal Cancer Screening in Cystic Fibrosis

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).

View Full Description

Full Description

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, greater than 3 months duration between stool-based testing and colonoscopy will be considered a protocol deviation.

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 months of submission of the stool sample.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Adults eligible for routine colon cancer screening: Adults with CF ages 40 - 75 years of age without history of transplant, or adults with CF age 30 - 75 who have had a transplant
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:

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

Study is for people with:

Colon Cancer

Estimated Enrollment:

350

Study ID:

NCT05362344

Recruitment Status:

Recruiting

Sponsor:

University of Washington, the Collaborative Health Studies Coordinating Center

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There are 24 Locations for this study

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Stanford University Medical Center
Palo Alto California, 94063, United States More Info
Sukhada Mairal, PhD
Contact
[email protected]
Monique Barakat, MD, PhD
Principal Investigator
Zachary M. Sellers, MD, PhD
Principal Investigator
National Jewish Health, University of Colorado
Denver Colorado, 80206, United States More Info
Alexandra Wilson, MD, RDN, CDE
Contact
303-270-2517
[email protected]
Rachel Janney
Contact
[email protected]
Jeffrey B. King, MD
Principal Investigator
University of Miami Hospital
Miami Florida, 33136, United States More Info
Ivan Whitaker, CRC
Contact
305-243-2568
[email protected]
Pamela Barletta
Contact
[email protected]
Maria G. Tupayachi-Ortiz, MD
Principal Investigator
Northwestern University
Chicago Illinois, 60611, United States More Info
Rachel Nelson, MS, MPH, CCRC
Contact
312-695-0415
[email protected]
Mia Calamari
Contact
[email protected]
Adam C. Stein, MD
Principal Investigator
University of Kansas Medical Center
Kansas City Kansas, 66160, United States More Info
Mary Manyara
Contact
913-588-8073
[email protected]
Lawrence Scott
Contact
913-588-4020
[email protected]
Joel D. Mermis, MD
Principal Investigator
Johns Hopkins Hospital, Johns Hopkins University
Baltimore Maryland, 21287, United States More Info
Azar Nouraky, RN
Contact
[email protected]
Britany Zeglin
Contact
[email protected]
Ken Y. Hui, MD
Principal Investigator
Massachusetts General Hospital
Boston Massachusetts, 02114, United States More Info
Rhea Saini
Contact
[email protected]
Christopher D. Vélez, MD
Principal Investigator
Boston Children's Hospital
Boston Massachusetts, 02115, United States More Info
Tucker Reynard
Contact
[email protected]
Olivia Killilea
Contact
[email protected]
Steven D. Freedman, MD
Principal Investigator
Michigan Medicine - University of Michigan
Ann Arbor Michigan, 48109, United States More Info
Jessica Carey
Contact
[email protected]
Dawn Kruse, CCRC
Contact
(734) 615-3266
[email protected]
Shijing Jia, MD
Principal Investigator
University of Minnesota
Minneapolis Minnesota, 55455, United States More Info
Dena Johnson
Contact
[email protected]
Mary Bailey, RRT
Contact
612-626-2743
[email protected]
Shahnaz Sultan, MD
Principal Investigator
Saint Louis University
Saint Louis Missouri, 63103, United States More Info
Freda Branch
Contact
314-678-5468
[email protected]
Sarah Schares
Contact
(314) 678-5457
[email protected]
Christine Hachem, MD
Principal Investigator
Washington University
Saint Louis Missouri, 63110, United States More Info
Sarah Smith
Contact
314-454-5175
[email protected]
Emily Burns
Contact
(314) 286-1781
[email protected]
Daniel B. Rosenbluth, MD
Principal Investigator
Columbia University Medical Center
New York New York, 10032, United States More Info
Rowena Fang
Contact
347-638-4112
[email protected]
Julian A. Abrams, MD
Principal Investigator
North Carolina Children's Hospital / UNC
Chapel Hill North Carolina, 27514, United States More Info
Margret Powell
Contact
984-974-2962
[email protected]
Scott H. Donaldson, MD
Principal Investigator
Atrium Health Pulmonary Care
Charlotte North Carolina, 28203, United States More Info
Jessica Kearney-Bryan, RN BSN CCRC
Contact
704-355-0244
[email protected]
Baharak Moshiree, MD
Principal Investigator
University Hospitals Rainbow Babies & Children's
Cleveland Ohio, 44106, United States More Info
Laura Batke
Contact
216-844-1316
[email protected]
Tia Rone
Contact
[email protected]
Linda Cummings, MD
Principal Investigator
Nationwide Children's Hospital
Columbus Ohio, 43205, United States More Info
Terri Johnson
Contact
614-722-4756
[email protected]
Laura Raterman
Contact
614-722-4758
[email protected]
Karen S. McCoy, MD
Principal Investigator
Oregon Health & Science University
Portland Oregon, 97239, United States More Info
Pierce Nusbaum
Contact
503-418-1169
[email protected]
Jenna Bucher
Contact
[email protected]
Aaron Trimble, MD
Principal Investigator
Hospital of the University of Pennsylvania
Philadelphia Pennsylvania, 19104, United States More Info
Sara Deitrick, MS, CCRC
Contact
917-216-7736
[email protected]
Melissa Molter
Contact
[email protected]
Daniel J. Dorgan, MD
Principal Investigator
Medical University of South Carolina
Charleston South Carolina, 29425, United States More Info
Ashley Warden
Contact
843-792-4349
[email protected]
Sheila Parnell
Contact
843-792-2375
[email protected]
Christina Mingora, MD
Principal Investigator
Vanderbilt University Medical Center
Nashville Tennessee, 37232, United States More Info
Valencia Bryant, CCRP, CRT
Contact
615-875-1060
[email protected]
James J. Tolle, MD
Principal Investigator
University of Texas Southwestern
Dallas Texas, 75390, United States More Info
Crystal Neugin, LVN
Contact
214-648-2817
[email protected]
Ashley Keller
Contact
214-648-6233
[email protected]
Raksha Jain, MD
Principal Investigator
University of Washington
Seattle Washington, 98195, United States More Info
Teresa Gambol
Contact
206-543-7382
[email protected]
Mark D. Derleth, MD
Principal Investigator
Medical College of Wisconsin
Milwaukee Wisconsin, 53226, United States More Info
Erin Hubertz, BA, CCRC
Contact
414-955-7019
[email protected]
Rose Franco, MD
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Colon Cancer

Estimated Enrollment:

350

Study ID:

NCT05362344

Recruitment Status:

Recruiting

Sponsor:


University of Washington, the Collaborative Health Studies Coordinating Center

How clear is this clinincal trial information?

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