ColoRectal CancerNCT03705897
PROSPR Project 1: Identifying and Tracking Personalized CRC Screening Regimens for Patients in Clinical Settings
A study testing Computerized Risk Stratification Tool, Algorithmic Risk Stratification Tool and Step completion assessment in people with ColoRectal Cancer, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
The overall goal of the Parkland-UT Southwestern Population-based Research Optimizing Screening through Personalized Regimens (PROSPR) Center is to optimize colon cancer screening through personalized regimens in the integrated safety-net clinical provider network, which serves a large and diverse population of under… Read more about this study
- Who is it for?
- Ages 25 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- ColoRectal Cancer
- What is being tested?
- Computerized Risk Stratification Tool, Algorithmic Risk Stratification Tool and Step completion assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9,264 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 25 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female patients, ages 25-64, presenting for appointment will be eligible to participate.
- Patients 25-49 must also have family hx of CRC or personal hx of inflammatory bowel disease or adenomatous polyps.
- No racial or ethnic group will be excluded from participation.
- Both English and Spanish speakers will be eligible for participation.
Who cannot join
- Patients with a personal history of CRC are not eligible to participate.
- Patients who do not speak Spanish or English or have severely impaired hearing or speech or do not give informed consent will also be excluded from participation.
Trial locations and contacts
1 site in 1 country.
About this study
The overall goal of the Parkland-UT Southwestern Population-based Research Optimizing Screening through Personalized Regimens (PROSPR) Center is to optimize colon cancer screening through personalized regimens in the integrated safety-net clinical provider network, which serves a large and diverse population of under- and un-insured patients in Dallas. Together, three research projects will assess clinic, system, and organizational factors associated with over-, under- and guideline-based screening among this important population and will compare benefits, harms, and costs of strategies for facilitating optimized screening regimens. The theme of optimizing colorectal cancer screening in a safety-net clinical provider network brings together several components. Its focus on colorectal cancer (CRC) screening which is important, because CRC is the second cancer killer in the US while being the only major cancer for which optimized screening results in primary prevention. Despite this strong potential benefit, CRC screening remains suboptimal overall, and especially among low-income and minority individuals served by safety-nets. Safety-net networks therefore offer tremendous potential for CRC prevention and control, but numerous factors at the clinics-, system-, and organization-level influence their ability to provide optimized care.
Read the detailed description
Each of the Population-based Research Optimizing Screening through Personalized Regimens (PROSPR) Center's projects is innovative and addresses the continuum of care. Project 1 addresses transitions 1 and 3, employing novel, algorithmically driven tools in clinics to determine personalized optimized screening regimens for individual patients and track whether each has received the indicated guideline-based screening. Project 2 addresses all three transitions through a novel comparative effectiveness study of benefits, risks, and costs of two outreach strategies for promoting screening completion and guideline-appropriate follow-up. Project 3 addresses transitions 2 and 3 by focusing on organizational culture, structure, and protocols, using both quantitative and qualitative methods to elucidate factors influencing completion of effective screening processes. These projects address research priorities identified through a recent National Institute of Health (NIH) State of the Science Conference, including: implementing interventions proven effective at increasing colorectal cancer (CRC) screening (Projects 1 \& 2), conducting research to assess effectiveness of tailoring programs to match characteristics and preferences of target populations (Project 1), implementing systems to ensure follow up of positive CRC screening results (Projects 1, 2 \& 3), and conducting studies to determine comparative effectiveness of CRC screening methods in usual practice (Project 2).
PROSPR Center's goals are to:
- Develop a Parkland-UT Southwestern PROSPR Center to promote coordinated, transdisciplinary research to evaluate and improve the CRC screening process in a large population-based safety-net.
- Conduct three projects that address the continuum of care for CRC screening and address these goals: Project 1- Employ innovative methods for assessing personalized guideline-based screening in the clinic setting to evaluate guideline-based, over- and under-screening; Project 2 - Compare benefits, harm, and costs of three system-level strategies for inviting patients to screening and promoting guideline-based follow up, with particular focus on completing an effective screening process. Project 3 - Examine specific organizational factors that contribute to completion of guideline-based screening processes and examine which organizational factors modify relationships between social disadvantage and completion of guideline-based repeat screening and follow up of abnormal test results.
- Contribute to a national PROSPR network by actively participating in network activities, including:
- collaborating with the National Data Coordinating Center regarding approaches for measuring screening effectiveness, (b) sharing algorithmically driven tools facilitating personalized screening regimes, (c) sharing electronic medical record (EMR) capabilities with other Epic institutions, and (d) becoming a leader in cancer screening processes in safety-net systems. While the SPDU will be exclusively responsible for all required PROSPR network data collection, processing and transfer activities, our complementary Shared Research Resources Core (SRRC) will serve as the local "data coordinating center" of our PROSPR center. The SRRC will work with Projects 1-3 to identify patients for recruitment; track study accrual; and manage, process, and analyze all Project data. The SRRC will also help assure consistent data definitions and terminology for harms, benefits, and other common domains across the screening process documentation unit (SPDU) and Projects. The SRRC and SPDU will work closely together as much of the required SPDU screening process data will be used by the SRRC to identify eligible patients for Projects 1-3, and ascertain the processes and outcomes of the CRC screening process for study participants. An innovative activity of the SRRC will be to extract from Epic a novel set of electronically derived measures of social disadvantage previously developed by the Parkland Center for Innovation.27 This will empower Projects 1 and 2 to examine the influence of these factors on the in-reach and out-reach programs, as well as provide Project 3 with critical explanatory variables to understand the impact of clinic-level organizational factors on the CRC screening process.
- Conditions
- ColoRectal Cancer
- Being tested
- Computerized Risk Stratification Tool, Algorithmic Risk Stratification Tool, Step completion assessment
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computerized Risk Stratification ToolOther
Implement a novel computerized risk stratification tool in Parkland community-oriented primary-care clinics that collects data directly from patients and uses a computerized algorithm system to generate their personalized guideline-based next steps in the screening regimen
Algorithmic Risk Stratification ToolOther
Implement a novel algorithmic risk stratification system in Parkland's endoscopy clinics that, based on test findings entered by colonoscopists, generates personalized guideline-based next steps in the screening regimen for patients with colorectal polyps removed at olonoscopy
Step completion assessmentOther
Assess completion of guideline-recommended steps in personalized screening regimens, under-screening, and over-screening
| Study group | Role | What they receive |
|---|---|---|
| Screening | Other | Employ innovative methods for assessing personalized guideline-based screening in the clinic setting to evaluate guideline-based, over- and under-screening. Interventions include Computerized Risk Stratification Tool, Algorithmic Risk Stratification Tool, and Step completion assessment. Receives: Other: Computerized Risk Stratification Tool; Other: Algorithmic Risk Stratification Tool; Other: Step completion assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients achieving appropriate screening regimen.
Proportion of patients achieving appropriate screening regimen.
Measured: Three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2018
- Study startAug 2013
- Primary completion30 Sep 2016
- Study completion31 Dec 2020
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.
- 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9,264 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Celette Skinner, University of Texas Southwestern Medical Center
- Investigators
- Celette Skinner, PhD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03705897
- Sponsor's protocol ID
- STU 102011-068
- Other IDs
- 1U54CA163308-01
- Status last verified
- Jul 2026
- First submitted
- 9 Feb 2017
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PROSPR Project 1: Identifying and Tracking Personalized CRC Screening Regimens for Patients in Clinical Settings
- ClinicalTrials.gov ID
- NCT03705897
- Acronym / sponsor ID
- STU 102011-068
- Conditions
- ColoRectal Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9,264 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Aug 2013
- Primary completion
- 30 Sep 2016 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 15 Oct 2018 (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.
The overall goal of the Parkland-UT Southwestern Population-based Research Optimizing Screening through Personalized Regimens (PROSPR) Center is to optimize colon cancer screening through personalized regimens in the integrated safety-net clinical provider network, which serves a large and diverse population of under- and un-insured patients in Dallas. Together, three research projects will assess clinic, system, and organizational factors associated with over-, under- and guideline-based screening among this important population and will compare benefits, harms, and costs of strategies for facilitating optimized screening regimens. The theme of optimizing colorectal cancer screening in a safety-net clinical provider network brings together several components. Its focus on colorectal cancer (CRC) screening which is important, because CRC is the second cancer killer in the US while being the only major cancer for which optimized screening results in primary prevention. Despite this strong potential benefit, CRC screening remains suboptimal overall, and especially among low-income and minority individuals served by safety-nets. Safety-net networks therefore offer tremendous potential for CRC prevention and control, but numerous factors at the clinics-, system-, and organization-level influence their ability to provide optimized care.
Detailed description
Each of the Population-based Research Optimizing Screening through Personalized Regimens (PROSPR) Center's projects is innovative and addresses the continuum of care. Project 1 addresses transitions 1 and 3, employing novel, algorithmically driven tools in clinics to determine personalized optimized screening regimens for individual patients and track whether each has received the indicated guideline-based screening. Project 2 addresses all three transitions through a novel comparative effectiveness study of benefits, risks, and costs of two outreach strategies for promoting screening completion and guideline-appropriate follow-up. Project 3 addresses transitions 2 and 3 by focusing on organizational culture, structure, and protocols, using both quantitative and qualitative methods to elucidate factors influencing completion of effective screening processes. These projects address research priorities identified through a recent National Institute of Health (NIH) State of the Science Conference, including: implementing interventions proven effective at increasing colorectal cancer (CRC) screening (Projects 1 \& 2), conducting research to assess effectiveness of tailoring programs to match characteristics and preferences of target populations (Project 1), implementing systems to ensure follow up of positive CRC screening results (Projects 1, 2 \& 3), and conducting studies to determine comparative effectiveness of CRC screening methods in usual practice (Project 2).
PROSPR Center's goals are to:
- Develop a Parkland-UT Southwestern PROSPR Center to promote coordinated, transdisciplinary research to evaluate and improve the CRC screening process in a large population-based safety-net.
- Conduct three projects that address the continuum of care for CRC screening and address these goals: Project 1- Employ innovative methods for assessing personalized guideline-based screening in the clinic setting to evaluate guideline-based, over- and under-screening; Project 2 - Compare benefits, harm, and costs of three system-level strategies for inviting patients to screening and promoting guideline-based follow up, with particular focus on completing an effective screening process. Project 3 - Examine specific organizational factors that contribute to completion of guideline-based screening processes and examine which organizational factors modify relationships between social disadvantage and completion of guideline-based repeat screening and follow up of abnormal test results.
- Contribute to a national PROSPR network by actively participating in network activities, including:
- collaborating with the National Data Coordinating Center regarding approaches for measuring screening effectiveness, (b) sharing algorithmically driven tools facilitating personalized screening regimes, (c) sharing electronic medical record (EMR) capabilities with other Epic institutions, and (d) becoming a leader in cancer screening processes in safety-net systems. While the SPDU will be exclusively responsible for all required PROSPR network data collection, processing and transfer activities, our complementary Shared Research Resources Core (SRRC) will serve as the local "data coordinating center" of our PROSPR center. The SRRC will work with Projects 1-3 to identify patients for recruitment; track study accrual; and manage, process, and analyze all Project data. The SRRC will also help assure consistent data definitions and terminology for harms, benefits, and other common domains across the screening process documentation unit (SPDU) and Projects. The SRRC and SPDU will work closely together as much of the required SPDU screening process data will be used by the SRRC to identify eligible patients for Projects 1-3, and ascertain the processes and outcomes of the CRC screening process for study participants. An innovative activity of the SRRC will be to extract from Epic a novel set of electronically derived measures of social disadvantage previously developed by the Parkland Center for Innovation.27 This will empower Projects 1 and 2 to examine the influence of these factors on the in-reach and out-reach programs, as well as provide Project 3 with critical explanatory variables to understand the impact of clinic-level organizational factors on the CRC screening process.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Screening | Other | Other: Computerized Risk Stratification Tool, Other: Algorithmic Risk Stratification Tool, Other: Step completion assessmentEmploy innovative methods for assessing personalized guideline-based screening in the clinic setting to evaluate guideline-based, over- and under-screening. Interventions include Computerized Risk Stratification Tool, Algorithmic Risk Stratification Tool, and Step completion assessment. |
Who may qualify
- Ages
- 25 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male or female patients, ages 25-64, presenting for appointment will be eligible to participate.
- Patients 25-49 must also have family hx of CRC or personal hx of inflammatory bowel disease or adenomatous polyps.
- No racial or ethnic group will be excluded from participation.
- Both English and Spanish speakers will be eligible for participation.
Key exclusion criteria (2 listed)
- Patients with a personal history of CRC are not eligible to participate.
- Patients who do not speak Spanish or English or have severely impaired hearing or speech or do not give informed consent will also be excluded from participation.
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 |
|---|---|---|
| Computerized Risk Stratification ToolImplement a novel computerized risk stratification tool in Parkland community-oriented primary-care clinics that collects data directly from patients and uses a computerized algorithm system to generate their personalized guideline-based next steps in the screening regimen | Other | Screening |
| Algorithmic Risk Stratification ToolImplement a novel algorithmic risk stratification system in Parkland's endoscopy clinics that, based on test findings entered by colonoscopists, generates personalized guideline-based next steps in the screening regimen for patients with colorectal polyps removed at olonoscopy | Other | Screening |
| Step completion assessmentAssess completion of guideline-recommended steps in personalized screening regimens, under-screening, and over-screening | Other | Screening |
Primary outcome
Proportion of patients achieving appropriate screening regimen.
Time frame: Three years
Proportion of patients achieving appropriate screening regimen.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
- 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.
Celette Skinner, PhD principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computerized Risk Stratification Tool, Algorithmic Risk Stratification Tool and Step completion assessment in people with ColoRectal Cancer, run by University of Texas Southwestern Medical Center 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 2 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: finished, as of the sponsor's last update on 14 Jul 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Proportion of patients achieving appropriate screening regimen. (time frame: Three years). 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 14 Jul 2026.