Cystic FibrosisNICE-CFNCT05362344
Colorectal Cancer Screening in Cystic Fibrosis
An observational study of Cystic Fibrosis and Colorectal Cancer, run by University of Washington, the Collaborative Health Studies Coordinating Center at 26 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cystic Fibrosis, Colorectal Cancer, Adenoma
- What is being tested?
- Stool tests
- Type of treatment
- Surgery or procedure
- How many people
- 350 participants
- Where
- 26 sitesUnited States
- Study dates
- 1 Sep 2022to 30 Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults 18-75 with cystic fibrosis (CF) eligible for routine colon cancer screening
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
26 sites in 1 country.
26 sites in 1 country
United States26 sites
Michigan Medicine - University of Michigan
Ann Arbor, Michigan, 48109-5212
Johns Hopkins Hospital, Johns Hopkins University
Baltimore, Maryland, 21287
Massachusetts General Hospital
Boston, Massachusetts, 02114
Boston Children's Hospital
Boston, Massachusetts, 02115
North Carolina Children's Hospital / UNC
Chapel Hill, North Carolina, 27514
Medical University of South Carolina
Charleston, South Carolina, 29425
Atrium Health Pulmonary Care
Charlotte, North Carolina, 28203
University Hospitals Rainbow Babies & Children's
Cleveland, Ohio, 44106
Nationwide Children's Hospital
Columbus, Ohio, 43205
University of Texas Southwestern
Dallas, Texas, 75390
National Jewish Health, University of Colorado
Denver, Colorado, 80206
University of Kansas Medical Center
Kansas City, Kansas, 66160
University of California, Los Angeles
Los Angeles, California, 90404
University of Miami Hospital
Miami, Florida, 33136
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
University of Minnesota
Minneapolis, Minnesota, 55455
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Columbia University Medical Center
New York, New York, 10032
Stanford University Medical Center
Palo Alto, California, 94063
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15219
Oregon Health & Science University
Portland, Oregon, 97239-3098
University of Utah
Salt Lake City, Utah, 84132-4701
University of Washington
Seattle, Washington, 98195
Saint Louis University
St Louis, Missouri, 63103
Washington University
St Louis, Missouri, 63110
About this study
Official title: A Multi-Center Study of Non-Invasive Colorectal Cancer Evaluation in Cystic Fibrosis (NICE-CF)
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).
Read the detailed 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, 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.
- Conditions
- Cystic Fibrosis, Colorectal Cancer, Adenoma
- Being tested
- Stool tests
- Keywords
- Cystic Fibrosis, Colorectal Cancer, Cancer screening, Adenoma
- Medical subject headings
- Cystic Fibrosis, Colorectal Neoplasms, Adenoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stool testsProcedure or surgery
Also called Stool-based Fecal Immunochemical Testing (FIT) test and Stool-based DNA test (Cologuard) test.
Non-invasive, stool-based tests for colorectal cancer screening.
| Study group | Role | What they receive |
|---|---|---|
| NICE-CF Cohort | Adults with CF ages 18 - 75 years who are due for a routine screening or surveillance colonoscopy for colon cancer. Receives: Procedure: Stool tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3-12 months
Secondary outcomes (1)
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
Measured: 3-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2022
- Study start1 Sep 2022
- Primary completion21 Mar 2025
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington, the Collaborative Health Studies Coordinating Center
- Sponsor type
- University, hospital or other
- Collaborators
- Cystic Fibrosis Foundation
- Responsible party
- Sponsor
- Investigators
- Christine Hachem, MD, Principal investigator, St. Louis UniversitySarah Jane Schwarzenberg, MD, Principal investigator, University of MinnesotaSteven D. Freedman, MD, PhD, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05362344
- Sponsor's protocol ID
- NICE-CF
- Acronym
- NICE-CF
- Status last verified
- Mar 2026
- First submitted
- 28 Apr 2022
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hachem 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.
PubMed 42248729
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center Study of Non-Invasive Colorectal Cancer Evaluation in Cystic Fibrosis (NICE-CF)
- ClinicalTrials.gov ID
- NCT05362344
- Acronym / sponsor ID
- NICE-CF / NICE-CF
- Conditions
- Cystic Fibrosis, Colorectal Cancer, Adenoma
- Keywords
- Cystic Fibrosis, Colorectal Cancer, Cancer screening, Adenoma
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- University of Washington, the Collaborative Health Studies Coordinating CenterUniversity, hospital or other
- Collaborators
- Cystic Fibrosis Foundation
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 21 Mar 2025 (actual)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 5 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed 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, 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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NICE-CF Cohort | – | Procedure: Stool testsAdults with CF ages 18 - 75 years who are due for a routine screening or surveillance colonoscopy for colon cancer. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults 18-75 with cystic fibrosis (CF) eligible for routine colon cancer screening
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stool testsAlso: Stool-based Fecal Immunochemical Testing (FIT) test and Stool-based DNA test (Cologuard) test.Non-invasive, stool-based tests for colorectal cancer screening. | Procedure or surgery | NICE-CF Cohort |
Primary outcome
Sensitivity of multi-target stool DNA test and quantitative fecal immunochemical (FIT) test
Time frame: 3-12 months
Negative predictive value (NPV) and sensitivity for detection of any adenomas, advanced adenomas, and CRC in stool-based testing.
1 secondary outcome
Specificity of multi-target stool DNA test and quantitative fecal immunochemical (FIT) test
Time frame: 3-12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2026.
- Derived from this study: PubMed 42248729Hachem 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christine Hachem, MD principal investigator
St. Louis University
Sarah Jane Schwarzenberg, MD principal investigator
University of Minnesota
Steven D. Freedman, MD, PhD principal investigator
Beth Israel Deaconess Medical Center
26 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cystic Fibrosis and Colorectal Cancer, run by University of Washington, the Collaborative Health Studies Coordinating Center at 26 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of multi-target stool DNA test and quantitative fecal immunochemical (FIT) test (time frame: 3-12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05362344, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2026.