Colorectal CancerNCT07230795
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
A study testing Intervention Arm in people with Colorectal Cancer, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 45 to 49 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Intervention Arm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7,120 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Sep 2025to 30 Nov 2026
- Phase
- Interventional
- 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 45 to 49 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- Prior history of CRC
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19003
About this study
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.
- Conditions
- Colorectal Cancer
- Being tested
- Intervention Arm
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention ArmOther
Also called Patient navigator
The intervention arm will consist of a trained CRC navigator who will conduct outreach and navigation by interviewing these patients according to a script that consists of a statement of research, confirms eligibility, communicates their relative increased risk of CRC, assesses and addresses barriers to completion of CRC screening, and offers an adapted validated questionnaire regarding these barriers for patients to complete asynchronously. The navigator will be able to address barriers such as lack of awareness/knowledge about screening, misinformation, negative attitudes and fear, scheduling, inability to afford the prep, and lack of transportation and escort. The calls performed by the patient navigator will not be recorded.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm - Navigator Assistance | Experimental | A trained CRC navigator who will conduct outreach and navigation by interviewing these patients according to a script that consists of a statement of research, confirms eligibility, communicates their relative increased risk of CRC, assesses and addresses barriers to completion of CRC screening, and offers an adapted validated questionnaire regarding these barriers for patients to complete asynchronously. The navigator will be able to address barriers such as lack of awareness/knowledge about screening, misinformation, negative attitudes and fear, scheduling, inability to afford the prep, and lack of transportation and escort. The calls performed by the patient navigator will not be recorded. Receives: Other: Intervention Arm |
| Control Arm - NO Navigator Assistance | No intervention | Patients in the control arm will be enrolled under a waiver. They will only receive standard of care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enrollment in the Navigator program
The patient navigation will assist in completing their colorectal cancer screening. The only test are either a fecal immunochemical test (FIT) or a colonoscopy. No other tests are required.
Measured: 12 month
Completion of colonoscopy or FIT testing
The patient navigation will assist in completing either a fecal immunochemical test (FIT) or a colonoscopy. The only test are either a fecal immunochemical test (FIT) or a colonoscopy. No other tests are required.
Measured: 12 month
Abnormal screening findings (positive FIT, abnormal colonoscopy findings). S
We will evaluate the effectiveness of the program on uptake of navigation and completion of CRC screening, rates of abnormal screening results, abnormal stool test follow-up with diagnostic colonoscopy, time to screening uptake, and CRC and precancerous lesion detection.
Measured: 12 month
Secondary outcomes (2)
Screening uptake
We will evaluate the effectiveness of the program on the uptake of navigation.
Measured: Firtst 3 month
Colonoscopy follow-up for abnormal FIT
We will evaluate the effectiveness of the program on the uptake of navigation and completion of colorectal cancer screening.
Measured: Firtst 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2025
- Study start29 Sep 2025
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Abramson Cancer Center at Penn MedicineThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 7,120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07230795
- Sponsor's protocol ID
- 09225
- Other IDs
- 858875
- Status last verified
- Oct 2025
- First submitted
- 8 Sep 2025
- Last updated
- 17 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07230795
- Acronym / sponsor ID
- 09225
- Conditions
- Colorectal Cancer
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 7,120 participants (estimated)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Study start
- 29 Sep 2025 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 17 Nov 2025 (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 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm - Navigator Assistance | Experimental | Other: Intervention ArmA trained CRC navigator who will conduct outreach and navigation by interviewing these patients according to a script that consists of a statement of research, confirms eligibility, communicates their relative increased risk of CRC, assesses and addresses barriers to completion of CRC screening, and offers an adapted validated questionnaire regarding these barriers for patients to complete asynchronously. The navigator will be able to address barriers such as lack of awareness/knowledge about screening, misinformation, negative attitudes and fear, scheduling, inability to afford the prep, and lack of transportation and escort. The calls performed by the patient navigator will not be recorded. |
| Control Arm - NO Navigator Assistance | No intervention | –Patients in the control arm will be enrolled under a waiver. They will only receive standard of care. |
Who may qualify
- Ages
- 45 to 49 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- Prior history of CRC
- 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)
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 |
|---|---|---|
| Intervention ArmAlso: Patient navigatorThe intervention arm will consist of a trained CRC navigator who will conduct outreach and navigation by interviewing these patients according to a script that consists of a statement of research, confirms eligibility, communicates their relative increased risk of CRC, assesses and addresses barriers to completion of CRC screening, and offers an adapted validated questionnaire regarding these barriers for patients to complete asynchronously. The navigator will be able to address barriers such as lack of awareness/knowledge about screening, misinformation, negative attitudes and fear, scheduling, inability to afford the prep, and lack of transportation and escort. The calls performed by the patient navigator will not be recorded. | Other | Intervention Arm - Navigator Assistance |
Primary outcome
Enrollment in the Navigator program
Time frame: 12 month
The patient navigation will assist in completing their colorectal cancer screening. The only test are either a fecal immunochemical test (FIT) or a colonoscopy. No other tests are required.
Completion of colonoscopy or FIT testing
Time frame: 12 month
The patient navigation will assist in completing either a fecal immunochemical test (FIT) or a colonoscopy. The only test are either a fecal immunochemical test (FIT) or a colonoscopy. No other tests are required.
Abnormal screening findings (positive FIT, abnormal colonoscopy findings). S
Time frame: 12 month
We will evaluate the effectiveness of the program on uptake of navigation and completion of CRC screening, rates of abnormal screening results, abnormal stool test follow-up with diagnostic colonoscopy, time to screening uptake, and CRC and precancerous lesion detection.
2 secondary outcomes
Screening uptake
Time frame: Firtst 3 month
Colonoscopy follow-up for abnormal FIT
Time frame: Firtst 3 month
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 17 Nov 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention Arm in people with Colorectal Cancer, run by Abramson Cancer Center at Penn Medicine at 1 site 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 4 inclusion and 4 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: enrolling by invitation, as of the sponsor's last update on 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Enrollment in the Navigator program (time frame: 12 month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Nov 2025.