NCT07230795Enrolling by invitation
AI-informed Colorectal Cancer (CRC) Screening Navigation vs. Standard of Care Among Screening-naive Penn Medicine Patients 45-49 Years Old to Increase CRC Screening Uptake
Source: ClinicalTrials.gov · Last updated 17 Nov 2025
Brief summary (registry, in English)
This project aims to use machine learning algorithms (MLA) to identify and risk-stratify individuals between the ages of 45-49 who are more likely to have colorectal pathology and merit prioritized CRC screening and patient navigation. Patients deemed to be at higher risk for CRC by MLA will be randomized to an intervention group to receive risk-informed patient navigation and a usual care control group. The patient navigation will assist in completing either a fecal immunochemical test (FIT) or a colonoscopy. For the usual care control group, patients may still receive patient navigation for colonoscopy assistance. A referral to a nurse navigator can be initiated by a healthcare staff member in the following ways: 1) procedure scheduling staff will provide navigator's contact number if the patient expresses difficulty with obtaining a ride home 2) endoscopy staff and physicians can message navigator electronically 3) PCPs can place a navigation order in the EHR for patients deemed to need additional support such as with prep, education, transportation 4) providers will directly contact the director of the navigation system (Dr. Carmen Guerra) for referral.
- Status (registry)
- Enrolling by invitation
- Study type
- Interventional
- Enrollment
- 7120 (estimated)
- First submitted
- 8 Sept 2025
- Start date
- 29 Sept 2025
- Primary completion date
- 30 Nov 2026
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Diseases
- Colorectal cancer
- NCT number
- NCT07230795
What you commit to
- Study type: Interventional
- Planned participants: 7120
- From 29 Sept 2025 to the primary completion date, 30 Nov 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior history of CRC
Other illness
- Late-stage cancer of any organ (stage 4)
- History of colectomy
- Demonstrated high-risk of colorectal cancer (e.g. inflammatory bowel disease, hereditary colorectal cancer syndromes)
Who the study is looking for
- Age 45-49
- Not up to date with CRC screening within the recommended period of time (colonoscopy within 10 years, FIT within 1 year, Cologuard within 3 years, sigmoidoscopy within 3-5 years)
- Have primary care providers in Penn Internal Medicine and Family Medicine Practices
- Have at least 1 outpatient CBC in the past 12 months.
Age in the registry: 45 years to 49 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Pennsylvania Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.