Colorectal CancermPATH-CloudNCT06441487
mPATH-Cloud for Colorectal Cancer Screening
A study testing Mobile Health Decision Support in people with Colorectal Cancer, run by UNC Lineberger Comprehensive Cancer Center at 2 sites in United States.
Trial summary
This study assesses the effectiveness of colorectal cancer (CRC) screening intervention, mobile Patient Technology for Health (mPATH™-Cloud), compared to usual care among subjects who are overdue for CRC screening according to recommendations of the United States Preventive Services Taskforce (USPSTF). Read more about this study
- Who is it for?
- Ages 45 to 73 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Mobile Health Decision Support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,062 participants
- Where
- 2 sitesUnited States
- Study dates
- 24 Jun 2025to 1 Jan 2029
- 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 73 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 45-73 years at time of enrollment
- At average risk for CRC ("average risk" is defined as those subjects who do not have any of the following: documented history in the EHR of CRC, colonic adenomas, family history of CRC, or diagnosis of inflammatory bowel disease)
- No record in the EHR of fecal occult blood test (FOBT)/FIT within 12 months, FIT-DNA within 3 years, colonoscopy within 10 years, sigmoidoscopy within 5 years, barium enema within 5 years, or computed tomography (CT) colonography within 10 years of the EHR query date
- No record in the EHR of any CRC diagnosis or total colectomy
- Active patient of the clinic as documented in the EHR (seen at least 2 times within the past 12 months)
- For the second and third study rounds only: No record of a positive (abnormal) CRC screening result in a previous study round
Who cannot join
- All individuals meeting any of the exclusion criteria at baseline will be excluded from study participation:
- Age younger than 45 years or older than 73 years at the time of enrollment
- Not at average risk for CRC ("average risk" is defined as those subjects who do not have any of the following: history with colorectal carcinoma, colonic adenomas, family history of colorectal carcinoma, or diagnosis of inflammatory bowel disease)
- Colorectal carcinoma screening in last 12 months Record in the electronic health record (HER) of fecal occult blood test (FOBT)/FIT within 12 months, FIT-DNA within 3 years, colonoscopy within 10 years, sigmoidoscopy within 5 years, barium enema within 5 years, or computed tomography (CT) colonography within 10 years of the EHR query date
- Record in the EHR any CRC diagnosis or total colectomy
- Not an active client of the clinic as documented in the EHR (not seen at least 2 times within the past 12 months)
- For second and third annual study rounds only: Record of a positive (abnormal) CRC screening result in a previous study round
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Lineberger Comphrehensive Cancer Center at University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
Wake Forest University
Winston-Salem, North Carolina, 27157
About this study
Official title: Evaluating a Remotely Delivered, Digital Health CRC Screening Intervention Among Racially Diverse Patients of a Community Health Center
This study assesses the effectiveness of colorectal cancer (CRC) screening intervention, mobile Patient Technology for Health (mPATH™-Cloud), compared to usual care among subjects who are overdue for CRC screening according to recommendations of the United States Preventive Services Taskforce (USPSTF). The trial randomly selects and enrolls 1,000 eligible subjects served by one federally qualified health center (FQHC) in North Carolina. Subjects are randomized to two study arms, Usual Care (Arm 1) or Mobile Health Decision Support (Arm 2).
Usual care consists of a visit-based screening recommendation to complete a stool test (e.g., FOBT, FIT, Cologuard) or referral to a screening colonoscopy. Subjects randomized to the Mobile Health Decision Support (Arm 2) are sent a message by text or US mail, depending on their preferred communication mode as indicated in the electronic health record (EHR), to visit the mPATH™-Cloud website. Subjects who engage with mPATH™-Cloud are invited to answer brief questions to confirm their eligibility and then view a short decision aid video designed to help people choose the CRC screening test (FIT or colonoscopy) that they would like to receive. After watching the video, subjects can choose a CRC screening test. Their primary care provider at the FQHC orders the appropriate test and, where indicated, refers the subjects to a colonoscopy. Subjects who request FIT screening and subjects who do not select any test receive a FIT mailed to their home address.
Read more
The primary outcome of interest is CRC screening completion within 6 months after randomization as assessed by EHR chart review. A completed screening is any of the following: colonoscopy completion (regardless of indication); 2) at least one FIT test with a normal result; or diagnostic colonoscopy following an abnormal FIT result. We hypothesize that we will observe a higher CRC screening completion rate in the Mobile Health Decision Support intervention arm (Arm 2).
This study includes up to three annual rounds of screening eligibility assessment and outreach. Repeated intervention rounds allow us to evaluate whether the intervention can improve adherence to USPSTF recommendations over time. During the intervention phase, Arm 1 receives usual care only.
Read the detailed description
Subjects randomized to the Mobile Health Decision Support intervention arm (Arm 2) receive a link to mobile Patient Technology for Health (mPATH™-Cloud), a digital health platform designed to alleviate the implementation burden on clinical teams by automating many key steps in the CRC screening process. If the subject uses mPATH-Cloud to select a screening test, mPATH-Cloud notifies the subject's primary care provider at the FQHC. Subjects who request colonoscopy are then referred by their primary care provider to colonoscopy as appropriate. Subjects who request FIT receive a FIT mailed to their home.
Primary outcome assessment: To assess intervention effectiveness, CRC screening completion within 6 months of randomization (primary outcome) is assessed by EHR chart review. Screening completion is defined as any of the following: colonoscopy completion (regardless of indication); at least one FIT test with a normal FIT result; or diagnostic colonoscopy following an abnormal FIT result.
Secondary outcome assessment: To assess intervention effectiveness on adherence to USPSTF recommendations over time (secondary outcome), the Mobile Health Decision Support intervention is offered annually to Arm 2 subjects for up to 3 consecutive years so long as the subject remains eligible and due for CRC screening as determined by EHR review.
CRC screening up-to-datedness will be assessed by EHR chart review over a period of three consecutive years. FIT should be repeated annually, and colonoscopy typically only needs to be repeated once every 10 years. Thus, subjects will be assigned one year per annual FIT completed (e.g., FIT in years 1, 2, and 3 would be assigned 3 years; FIT in year 1, and 3 would be assigned 2 years) and up to 3 years for colonoscopy depending on the year received (e.g., colonoscopy in year 1 would be assigned 3 years, colonoscopy in year 3 would be assigned 1 year). Subjects remain in their originally assigned study arms for the duration of up to three annual rounds of CRC screening outreach.
Implementation assessment (exploratory outcome): This study will identify implementation processes and outcomes that will impact future dissemination and scalability. After the trial phase concludes, researchers will interview a subsample of up to 50 subjects to understand factors associated with CRC screening completion among subjects with varying needs and preferences.
- Conditions
- Colorectal Cancer
- Being tested
- Mobile Health Decision Support, Usual care
- Keywords
- screening, digital health platform, mPATH™, Mobile Patient Technology for Health, fecal immunochemical tests, fecal occult blood test, Cancer Screening, Community Health Centers, Implementation Science, Rural health, Telemedicine, Minority Health
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile Health Decision SupportBehavioural
Also called mPATH™-Cloud
Subjects randomized to this arm receive a link to a mobile health decision support tool (mPATH™- Cloud). Within mPATH™-Cloud, subjects are invited to answer brief questions to confirm eligibility, view a video to help them identify their CRC screening preference, and request either colonoscopy or fecal immunochemical test (FIT) screening from their primary care provider. Subjects who select FIT, as well as subjects who do not click on the link or select a screening test receive a FIT mailed to their home address.
Usual careBehavioural
The study team will send subjects a prompt to visit the mobile health decision support tool (mPATH™-Cloud). Subjects with a mobile phone (as determined by their electronic health record) will receive a link to mPATH-Cloud by text. Subjects with a mailing address, but no mobile phone number in the EHR, will receive a letter inviting them to access mPATH-Cloud via URL code. Within mPATH-Cloud, subjects are invited to answer brief questions to confirm eligibility, view a video to help them identify their CRC screening preference, and request either colonoscopy or fecal immunochemical test (FIT) screening from their primary care provider. Subjects who do not click on the link or select a screening test receive a FIT.
| Study group | Role | What they receive |
|---|---|---|
| Trial Mailed FIT Intervention | Experimental | Subjects randomized to this arm receive a link to a mobile health decision support tool (mPATH™-Cloud). Within mPATH™-Cloud, subjects are invited to answer brief questions to confirm eligibility, view a video to help them identify their CRC screening preference, and request either colonoscopy or fecal immunochemical test (FIT) screening from their primary care provider. Subjects who do not click on the link or select a screening test receive a FIT mailed to their home address. Receives: Behavioral: Mobile Health Decision Support |
| Trial Usual Care | Active comparator | Subjects randomized to this arm receive usual care. Current usual care at the participating community health centers consists of a visit-based colorectal cancer screening recommendation and referral. Receives: Behavioral: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Colorectal cancer screening completion rate
The proportion of individuals who completed CRC screening using any of the screening modalities recommended by the United States Preventive Service Task Force. Screening modalities could be fecal occult blood test (FIT), fecal occult blood test (FOBT), the stool DNA test combines the FIT ( FIT-DNA), colonoscopy, flexible sigmoidoscopy, flexible sigmoidoscopy with FIT, Computerized Tomography (CT) colonography.
Measured: Up to 6 months
Secondary outcomes (1)
Colorectal cancer screening up-to-datedness
Colorectal cancer screening coverage at the time of annual assessment. screening modalities recommended by the United States Preventive Service Task Force. Screening modalities could be fecal occult blood test (FIT), fecal occult blood test (FOBT), the stool DNA test combines the FIT ( FIT-DNA), colonoscopy, flexible sigmoidoscopy, flexible sigmoidoscopy with FIT, Computerized Tomography (CT) colonography.
Measured: Up-to-date status assessed 12 months after baseline for unscreened or 12 months after screening completion if screened within 12 months. Total follow-up up to 30 months post-baseline. Round 2 anchored to baseline or screening date if within 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2024
- Study start24 Jun 2025
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jan 2029 (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 Colorectal CancerStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized: Participants are assigned to intervention groups by chance.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,062 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Leah M Frerichs, PhD, Principal investigator, UNC Lineberger Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06441487
- Sponsor's protocol ID
- 23-1969
- Other IDs
- R01CA260822
- Acronym
- mPATH-Cloud
- Status last verified
- Apr 2026
- First submitted
- 22 May 2024
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All of the participant data collected during the trial, after de-identification, will be made available. IPD Sharing Supporting Information Type: Study Protocol, SAP, and Analytic Code. IPD Sharing Time Frame: Beginning 6 months after summary data are published or otherwise made available with no end date. IPD Sharing Access Criteria: Investigators who provide a methodologically sound proposal to achieve aims in the approved proposal. Proposals should be directed to leahf@unc.edu.
Publications
Frerichs L, Zhang Z, Moore AA, Falk I, Tan X, Randazzo A, Brenner AT, S Reuland D, Dharod A, Miller DP Jr. Using a digital health platform to implement a multi-component CRC screening intervention within a federally qualified health center: study protocol for a hybrid type I trial. BMC Health Serv Res. 2025 Aug 8;25(1):1047. doi: 10.1186/s12913-025-13262-y.
PubMed 40781671
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating a Remotely Delivered, Digital Health CRC Screening Intervention Among Racially Diverse Patients of a Community Health Center
- ClinicalTrials.gov ID
- NCT06441487
- Acronym / sponsor ID
- mPATH-Cloud / 23-1969
- Conditions
- Colorectal Cancer
- Keywords
- screening, digital health platform, mPATH™, Mobile Patient Technology for Health, fecal immunochemical tests, fecal occult blood test, Cancer Screening, Community Health Centers
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,062 participants (actual)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Study start
- 24 Jun 2025 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Jan 2029 (estimated)
- First posted
- 4 Jun 2024 (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 study assesses the effectiveness of colorectal cancer (CRC) screening intervention, mobile Patient Technology for Health (mPATH™-Cloud), compared to usual care among subjects who are overdue for CRC screening according to recommendations of the United States Preventive Services Taskforce (USPSTF). The trial randomly selects and enrolls 1,000 eligible subjects served by one federally qualified health center (FQHC) in North Carolina. Subjects are randomized to two study arms, Usual Care (Arm 1) or Mobile Health Decision Support (Arm 2).
Usual care consists of a visit-based screening recommendation to complete a stool test (e.g., FOBT, FIT, Cologuard) or referral to a screening colonoscopy. Subjects randomized to the Mobile Health Decision Support (Arm 2) are sent a message by text or US mail, depending on their preferred communication mode as indicated in the electronic health record (EHR), to visit the mPATH™-Cloud website. Subjects who engage with mPATH™-Cloud are invited to answer brief questions to confirm their eligibility and then view a short decision aid video designed to help people choose the CRC screening test (FIT or colonoscopy) that they would like to receive. After watching the video, subjects can choose a CRC screening test. Their primary care provider at the FQHC orders the appropriate test and, where indicated, refers the subjects to a colonoscopy. Subjects who request FIT screening and subjects who do not select any test receive a FIT mailed to their home address.
The primary outcome of interest is CRC screening completion within 6 months after randomization as assessed by EHR chart review. A completed screening is any of the following: colonoscopy completion (regardless of indication); 2) at least one FIT test with a normal result; or diagnostic colonoscopy following an abnormal FIT result. We hypothesize that we will observe a higher CRC screening completion rate in the Mobile Health Decision Support intervention arm (Arm 2).
This study includes up to three annual rounds of screening eligibility assessment and outreach. Repeated intervention rounds allow us to evaluate whether the intervention can improve adherence to USPSTF recommendations over time. During the intervention phase, Arm 1 receives usual care only.
Detailed description
Subjects randomized to the Mobile Health Decision Support intervention arm (Arm 2) receive a link to mobile Patient Technology for Health (mPATH™-Cloud), a digital health platform designed to alleviate the implementation burden on clinical teams by automating many key steps in the CRC screening process. If the subject uses mPATH-Cloud to select a screening test, mPATH-Cloud notifies the subject's primary care provider at the FQHC. Subjects who request colonoscopy are then referred by their primary care provider to colonoscopy as appropriate. Subjects who request FIT receive a FIT mailed to their home.
Primary outcome assessment: To assess intervention effectiveness, CRC screening completion within 6 months of randomization (primary outcome) is assessed by EHR chart review. Screening completion is defined as any of the following: colonoscopy completion (regardless of indication); at least one FIT test with a normal FIT result; or diagnostic colonoscopy following an abnormal FIT result.
Secondary outcome assessment: To assess intervention effectiveness on adherence to USPSTF recommendations over time (secondary outcome), the Mobile Health Decision Support intervention is offered annually to Arm 2 subjects for up to 3 consecutive years so long as the subject remains eligible and due for CRC screening as determined by EHR review.
CRC screening up-to-datedness will be assessed by EHR chart review over a period of three consecutive years. FIT should be repeated annually, and colonoscopy typically only needs to be repeated once every 10 years. Thus, subjects will be assigned one year per annual FIT completed (e.g., FIT in years 1, 2, and 3 would be assigned 3 years; FIT in year 1, and 3 would be assigned 2 years) and up to 3 years for colonoscopy depending on the year received (e.g., colonoscopy in year 1 would be assigned 3 years, colonoscopy in year 3 would be assigned 1 year). Subjects remain in their originally assigned study arms for the duration of up to three annual rounds of CRC screening outreach.
Implementation assessment (exploratory outcome): This study will identify implementation processes and outcomes that will impact future dissemination and scalability. After the trial phase concludes, researchers will interview a subsample of up to 50 subjects to understand factors associated with CRC screening completion among subjects with varying needs and preferences.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized: Participants are assigned to intervention groups by chance.
| Arm | Type | Receives |
|---|---|---|
| Trial Mailed FIT Intervention | Experimental | Behavioral: Mobile Health Decision SupportSubjects randomized to this arm receive a link to a mobile health decision support tool (mPATH™-Cloud). Within mPATH™-Cloud, subjects are invited to answer brief questions to confirm eligibility, view a video to help them identify their CRC screening preference, and request either colonoscopy or fecal immunochemical test (FIT) screening from their primary care provider. Subjects who do not click on the link or select a screening test receive a FIT mailed to their home address. |
| Trial Usual Care | Active comparator | Behavioral: Usual careSubjects randomized to this arm receive usual care. Current usual care at the participating community health centers consists of a visit-based colorectal cancer screening recommendation and referral. |
Who may qualify
- Ages
- 45 to 73 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 45-73 years at time of enrollment
- At average risk for CRC ("average risk" is defined as those subjects who do not have any of the following: documented history in the EHR of CRC, colonic adenomas, family history of CRC, or diagnosis of inflammatory bowel disease)
- No record in the EHR of fecal occult blood test (FOBT)/FIT within 12 months, FIT-DNA within 3 years, colonoscopy within 10 years, sigmoidoscopy within 5 years, barium enema within 5 years, or computed tomography (CT) colonography within 10 years of the EHR query date
- No record in the EHR of any CRC diagnosis or total colectomy
- Active patient of the clinic as documented in the EHR (seen at least 2 times within the past 12 months)
Key exclusion criteria (7 listed)
- All individuals meeting any of the exclusion criteria at baseline will be excluded from study participation:
- Age younger than 45 years or older than 73 years at the time of enrollment
- Not at average risk for CRC ("average risk" is defined as those subjects who do not have any of the following: history with colorectal carcinoma, colonic adenomas, family history of colorectal carcinoma, or diagnosis of inflammatory bowel disease)
- Colorectal carcinoma screening in last 12 months Record in the electronic health record (HER) of fecal occult blood test (FOBT)/FIT within 12 months, FIT-DNA within 3 years, colonoscopy within 10 years, sigmoidoscopy within 5 years, barium enema within 5 years, or computed tomography (CT) colonography within 10 years of the EHR query date
- Record in the EHR any CRC diagnosis or total colectomy
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 |
|---|---|---|
| Mobile Health Decision SupportAlso: mPATH™-CloudSubjects randomized to this arm receive a link to a mobile health decision support tool (mPATH™- Cloud). Within mPATH™-Cloud, subjects are invited to answer brief questions to confirm eligibility, view a video to help them identify their CRC screening preference, and request either colonoscopy or fecal immunochemical test (FIT) screening from their primary care provider. Subjects who select FIT, as well as subjects who do not click on the link or select a screening test receive a FIT mailed to their home address. | Behavioural | Trial Mailed FIT Intervention |
| Usual careThe study team will send subjects a prompt to visit the mobile health decision support tool (mPATH™-Cloud). Subjects with a mobile phone (as determined by their electronic health record) will receive a link to mPATH-Cloud by text. Subjects with a mailing address, but no mobile phone number in the EHR, will receive a letter inviting them to access mPATH-Cloud via URL code. Within mPATH-Cloud, subjects are invited to answer brief questions to confirm eligibility, view a video to help them identify their CRC screening preference, and request either colonoscopy or fecal immunochemical test (FIT) screening from their primary care provider. Subjects who do not click on the link or select a screening test receive a FIT. | Behavioural | Trial Usual Care |
Primary outcome
Colorectal cancer screening completion rate
Time frame: Up to 6 months
The proportion of individuals who completed CRC screening using any of the screening modalities recommended by the United States Preventive Service Task Force. Screening modalities could be fecal occult blood test (FIT), fecal occult blood test (FOBT), the stool DNA test combines the FIT ( FIT-DNA), colonoscopy, flexible sigmoidoscopy, flexible sigmoidoscopy with FIT, Computerized Tomography (CT) colonography.
1 secondary outcome
Colorectal cancer screening up-to-datedness
Time frame: Up-to-date status assessed 12 months after baseline for unscreened or 12 months after screening completion if screened within 12 months. Total follow-up up to 30 months post-baseline. Round 2 anchored to baseline or screening date if within 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 30 Apr 2026.
- Derived from this study: PubMed 40781671Frerichs L, Zhang Z, Moore AA, Falk I, Tan X, Randazzo A, Brenner AT, S Reuland D, Dharod A, Miller DP Jr. Using a digital health platform to implement a multi-component CRC screening intervention within a federally qualified health center: study protocol for a hybrid type I trial. BMC Health Serv Res. 2025 Aug 8;25(1):1047. doi: 10.1186/s12913-025-13262-y.
- Clinical trials at UNC LinebergerLink provided by the sponsor.
- Individual participant dataSharing planned: No. All of the participant data collected during the trial, after de-identification, will be made available. IPD Sharing Supporting Information Type: Study Protocol, SAP, and Analytic Code. IPD Sharing Time Frame: Beginning 6 months after summary data are published or otherwise made available with no end date. IPD Sharing Access Criteria: Investigators who provide a methodologically sound proposal to achieve aims in the approved proposal. Proposals should be directed to leahf@unc.edu.
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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.
Leah M Frerichs, PhD principal investigator
UNC Lineberger Comprehensive Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile Health Decision Support in people with Colorectal Cancer, run by UNC Lineberger Comprehensive Cancer Center at 2 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 6 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 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Colorectal cancer screening completion rate (time frame: Up to 6 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 NCT06441487, 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 30 Apr 2026.